Business of Medicine

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.

A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.

For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual.

For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.

While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.

The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.

Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.

Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.

Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.

Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.

The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.

Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.

Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.

You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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

Editor’s note: This is the second in a two-part series commemorating the 100-year anniversary of the first use of insulin in humans. Part 1 of this series examined the rivalry behind the discovery and use of insulin.

One hundred years ago, teenager Leonard Thompson was the first patient with type 1 diabetes to be successfully treated with insulin, granting him a reprieve from what was a certain death sentence at the time.

Since then, research has gathered pace. In the century since insulin’s discovery and first use, recombinant DNA technology has allowed for the engineering of the insulin molecule, providing numerous short- and long-acting analog versions. At the same time, technological leaps in automated insulin delivery and monitoring of blood glucose ensure more time with glucose in range and fewer life-threatening complications for those with type 1 diabetes fortunate enough to have access to the technology. 

In spite of these advancements, there is still scope for further evolution of disease management, with the holy grail being the transplant of stem cell–derived islet cells capable of making insulin, ideally encased in some kind of protective device so that immunosuppression is not required.

Indeed, it is not unreasonable to “hope that type 1 diabetes will be a curable disease in the next 100 years,” said Elizabeth Stephens, MD, an endocrinologist who has type 1 diabetes and practices in Portland, Ore.
 

Type 1 diabetes: The past 100 years

The epidemiology of type 1 diabetes has shifted considerably since 1922. A century ago, given that average life expectancy in the United States was around 54 years, it was pretty much the only type of diabetes that doctors encountered. “There was some type 2 diabetes about in heavier people, but the focus was on type 1 diabetes,” noted Dr. Stephens.

Originally called juvenile diabetes because it was thought to only occur in children, “now 50% of people are diagnosed with type 1 diabetes ... over [the age of] 20,” explained Dr. Stephens.

In the United States, around 1.4 million adults 20 years and older, and 187,000 children younger than 20, have the disease, according to data from the National Diabetes Statistics Report 2020 by the Centers for Disease Control and Prevention. This total represents an increase of nearly 30% from 2017.

Over the years, theories as to the cause, or trigger, for type 1 diabetes “have included cow’s milk and [viral] infections,” said Dr. Stephens. “Most likely, there’s a genetic predisposition and some type of exposure, which creates the perfect storm to trigger disease.”

There are hints that COVID-19 might be precipitating type 1 diabetes in some people. Recently, the CDC found SARS-CoV-2 infection was associated with an increased risk for diabetes (all types) among youth, but not other acute respiratory infections. And two further studies from different parts of the world have recently identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons remain unclear.

The global CoviDiab registry has also been established to collect data on patients with COVID-19–related diabetes.

The million-dollar question: Is COVID-19 itself is propagating type 1 diabetes or unmasking a predisposition to the disease sooner? The latter might be associated with a lower type 1 diabetes rate in the future, said Partha Kar, MBBS, OBE, national specialty advisor, diabetes, for National Health Service England.

“Right now, we don’t know the answer. Whichever way you look at it, it is likely there will be a rise in cases, and in countries where insulin is not freely available, healthcare systems need to have supply ready because insulin is lifesaving in type 1 diabetes,” Dr. Kar emphasized.
 

CGMs and automated insulin delivery: A ‘godsend’

A huge change has also been seen, most notably in the past 15 to 20 years, in the technological advancements that can help those with type 1 diabetes live an easier life.

Continuous glucose monitors (CGMs) and automated ways of delivering insulin, such as smart pens and insulin pumps, have made the daily life of a person with type 1 diabetes in the Western world considerably more comfortable.

CGMs provide a constant stream of data to an app, often wirelessly in sync with the insulin pump. However, on a global level, they are only available to a lucky few.

In England, pending National Institute for Health and Care Excellence) approval, any CGM should be available to all eligible patients with type 1 diabetes within the NHS from April 2022, Dr. Kar pointed out. In the United States, CGMs are often unaffordable and access is mostly dependent on a person’s health insurance.

Kersten Hall, PhD, a scientist and U.K.-based medical historian who recently wrote a book, “Insulin, the Crooked Timber” (Oxford, England: Oxford University Press, 2022) uncovering the lesser-known story behind the discovery of insulin, was diagnosed with adult-onset type 1 diabetes at the age of 41. Dr. Hall had always found the finger-prick blood glucose test to be a chore but now has a CGM. 

“It’s a total game changer for me: a godsend. I can’t sing its praises enough,” he said. “All it involves is the swipe of the phone and this provides a reading which tells me if my glucose is too low, so I eat something, or too high, so I might [go for] a run.”
 

Brewing insulin at scale

As described by Dr. Hall in his book, the journey from treating Mr. Thompson in 1922 to treating the masses began when biochemist James Collip, MD, PhD, discovered a means of purifying the animal pancreas extracts used to treat the teenager.

But production at scale presented a further challenge. This was overcome in 1924 when Eli Lilly drew on a technique used in the beer brewing process – where pH guides bitterness – to purify and manufacture large amounts of insulin.

By 1936, a range of slower-acting cattle and pig-derived insulins, the first produced by Novo Nordisk Pharmaceuticals, were developed.

However, it took 8,000 lb (approximately 3,600 kg) of pancreas glands from 23,500 animals to make 1 lb (0.5 kg) of insulin, so a more efficient process was badly needed.

Dr. Hall, who is a molecular biologist as well as an author, explains that the use of recombinant DNA technology to produce human insulin, as done by Genentech in the late 70s, was a key development in the story of modern insulin products. Genentech then provided synthetic human insulin for Eli Lilly to conduct clinical trials.

Human insulin most closely resembles porcine insulin structure and function, differing by only one amino acid, while human insulin differs from bovine insulin by three amino acid residues. This synthetic human insulin eliminated the allergies that the animal-derived products sometimes caused.

In the early 1980s, Eli Lilly produced Humulin, the first biosynthetic (made in Escherichia coli, hence the term, “bio”) human insulin.

This technology eventually “allowed for the alteration of specific amino acids in the sequence of the insulin protein to make insulin analogs [synthetic versions grown in E. coli and genetically altered for various properties] that act faster, or more slowly, than normal human insulin. By using the slow- and fast-acting insulins in combination, a patient can control their blood sugar levels with a much greater degree of finesse and precision,” Dr. Hall explained.

Today, a whole range of insulins are available, including ultra–rapid-acting, short-acting, intermediate-acting, long-acting, ultra–long-acting, and even inhaled insulin, although the latter is expensive, has been associated with side effects, and is less commonly used, according to Dr. Stephens.

Oral insulin formulations are even in the early stages of development, with candidate drugs by Generex and from the Oralis project.

“With insulin therapy, we try to reproduce the normal physiology of the healthy body and pancreas,” Dr. Stephens explained.

Insulin analogs are only made by three companies (Eli Lilly, Novo Nordisk, and Sanofi), and they are generally much more expensive than nonanalog human insulin. In the United Kingdom through the NHS, they cost twice as much.

In the United States today, one of the biggest barriers to proper care of type 1 diabetes is the cost of insulin, which can limit access. With the market controlled by these three large companies, the average cost of a unit of insulin in the United States, according to RAND research, was $98.17 in January 2021, compared with $7.52 in the United Kingdom and $12.00 in Canada. 

Several U.S. states have enacted legislation capping insulin copayments to at, or under, $100 a month. But the federal Build Back Better Framework Act – which would cap copayments for insulin at $35 – currently hangs in the balance.

Alongside these moves, in 2020 the Food and Drug Administration approved the first interchangeable biosimilar insulin for type 1 diabetes (and insulin-dependent type 2 diabetes) in children and adults, called Semglee (Mylan Pharmaceuticals). 

Biosimilars (essentially generic versions of branded insulins) are expected to be less expensive than branded analogs, but the indications so far are that they will only be around 20% cheaper.

“I totally fail to understand how the richest country in the world still has a debate about price caps, and we are looking at biosimilar markets to change the debate. This makes no sense to me at all,” stressed Dr. Kar. “For lifesaving drugs, they should be funded by the state.”

Insulin also remains unaffordable for many in numerous low- and middle-income countries, where most patients pay out-of-pocket for medicines. Globally, there are estimated to be around 30 million people who need insulin but cannot afford it.

How near to a cure in the coming decades?

Looking ahead to the coming years, if not the next 100, Dr. Stephens highlighted two important aspects of care.

First, the use of a CGM device in combination with an insulin pump (also known as a closed-loop system or artificial pancreas), where the CGM effectively tells the insulin pump how much insulin to automatically dispense, should revolutionize care.

A number of such closed-loop systems have recently been approved in both the United States, including systems from Medtronic and Omnipod, and Europe.

“I wear one of these and it’s been a life changer for me, but it doesn’t suit everyone because the technology can be cumbersome, but with time, hopefully things will become smaller and more accurate in insulin delivery,” Dr. Stephens added.

The second advance of interest is the development and transplantation of cells that produce insulin.

Dr. Stephens explained that someone living with type 1 diabetes has a lot to think about, not least, doing the math related to insulin requirement. “If we just had cells from a pancreas that could be transplanted and would do that for us, then it would be a total game changer.”

To date, Vertex Pharmaceuticals has successfully treated one patient – who had lived with type 1 diabetes for about 40 years and had recurrent episodes of severe hypoglycemia – with an infusion of stem cell–derived differentiated islet cells into his liver. The procedure resulted in near reversal of type 1 diabetes, with his insulin dose reduced from 34 to 3 units, and his hemoglobin A1c falling from 8.6% to 7.2%.

And although the patient, Brian Shelton, still needs to take immunosuppressive agents to prevent rejection of the stem cell–derived islets, “it’s a whole new life,” he recently told the New York Times.  

Another company called ViaCyte is also working on a similar approach.

Whether this is a cure for type 1 diabetes is still debatable, said Anne Peters, MD, of the University of Southern California, Los Angeles. “Is it true? In a word, no. But we are part of the way there, which is much closer than we were 6 months ago.”

There are also ongoing clinical trials of therapeutic interventions to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes. The most advanced is the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio), which was rejected by the FDA in July 2021, but has since been refiled. The company expects to hear from the agency by the end of March 2022 as to whether the resubmission has been accepted.
 

Diabetes specialist nurses/educators keep it human

Dr. Hall said he concurs with the late eminent U.K. diabetes specialist Robert Tattersall’s observation on what he considers one of the most important advances in the management and treatment of type 1 diabetes: the human touch.

Referring to Dr. Tattersall’s book, “Diabetes: A Biography,” Dr. Hall quoted: “If asked what innovation had made the most difference to their lives in the 1980s, patients with type 1 diabetes in England would unhesitatingly have chosen not human insulin, but the spread of diabetes specialist nurses ... these people (mainly women) did more in the last two decades of the 20th century to improve the standard of diabetes care than any other innovation or drug.”

In the United States, diabetes specialist nurses were called diabetes educators until recently, when the name changed to certified diabetes care and education specialist.

“Above all, they have humanized the service and given the patient a say in the otherwise unequal relationship with all-powerful doctors,” concluded Dr. Hall, again quoting Dr. Tattersall.

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

On the morning of Feb. 24, rheumatologist Olena Garmish woke at 5:50 a.m. from the blasts of rocket fire in Kiev, Ukraine, and saw the explosions through her window

She described that next week to this news organization: air sirens 20 hours a day, fearing death 24 hours a day, and growing food shortages.

Dr. Garmish, executive director of the Association of Rheumatologists of Ukraine, said she continued working at a Kiev hospital until March 4, but then had to leave the country with her children and has traveled to two other countries since. Now she is looking for employment abroad after 22 years as a clinical researcher and practitioner.

omersukrugoksu/Getty Images

“We lost our jobs and rheumatology practice,” she said. Now, she says, she provides online consultations to patients as much as she can.

As air strikes continued Tuesday in Ukraine’s capital city and elsewhere throughout the country, rheumatologists are among citizens forced to upend their personal and professional lives and make the best decisions they can to keep themselves and their families safe.

Roman Yatsyshyn, MD, professor at Ivano-Frankivsk National Medical University in Ivano-Frankivsk, Ukraine, and vice president of the Association of Rheumatologists of Ukraine, told this news organization that many rheumatologists, like Dr. Garmish, have been forced to close their practices and flee the country. The hope is that the moves are temporary, he said.

He said rheumatologists there are having very different experiences depending on their proximity to the shelling.

Dmytro Rekalov, MD, PhD, who has been a practicing rheumatologist for 20 years, said he has had to relocate – he hopes temporarily – to western Ukraine.

He told this news organization that the battles are about 40 km (25 miles) from him.

“I have a small private rheumatology clinic in Zaporizhzhia [in southeastern Ukraine], so if they invade our city, I’ll have to close my clinic and find another place to live and to practice in.” Zaporizhzhia is home to the largest nuclear plant in Europe, a facility that came under attack earlier this month.

Doctors from areas under siege have been forced to move to quieter locations and consult with patients remotely, Dr. Yatsyshyn said.  

“Moreover, all doctors are actively volunteering, helping refugees, and supporting our military at the front,” he said, adding that medications are in short supply.

“We express our sincere gratitude to the world and European medical communities for their help for Ukraine at this time. Medicines and medical devices come to Ukraine from many countries around the world every day,” he said.

Dr. Yatsyshyn said the Ministry of Health of Ukraine is coordinating delivery of medications.

“However, there is still a need for an uninterrupted supply of basic antirheumatic drugs, cytostatics, glucocorticosteroids, analgesics, and nonsteroidal anti-inflammatory drugs. We will be grateful if such help will continue to come from our colleagues,” Dr. Yatsyshyn said.

In most cases, he says, rheumatologists stay in touch with their patients via social media and apps, Skype, and Zoom.

“We have also created professional and patient groups in chat rooms,” he said. “There, we can respond quickly to current issues in different regions. If necessary, we send medicines in case of their absence or danger in certain regions of the country. Rheumatologists have set up a joint group for online counseling and exchange.”

Some rheumatologists have been retrained as emergency physicians, he said. In areas with less military activity, rheumatologists continue to treat patients at their practices. In places where it is relatively calm, rheumatologists consult not only local patients but also migrants from other regions affected by the war, Dr. Yatsyshyn explained.

The Association of Rheumatologists of Ukraine continues its activities, he said.

“We monitor the problems of our colleagues, their relocations, security, and the opportunity to work. In close cooperation with the Ministry of Health, we monitor the provision of necessary medicines to our patients. We are very grateful for the help of our colleagues from European associations, the United States, pharmaceutical companies, medical centers, universities, and volunteer organizations.”

“We have two other big requests to the entire medical and scientific community,” Dr. Yatsyshyn said. “To suspend the membership of all Russian medical communities in European and world associations (including EULAR, EUSTAR, Lupus Academy, ACR, British Society of Rheumatology, and others) with a ban on attending international forums just as almost all sports and art organizations in Europe and the civilized world have done.”

The second request, he said, is “to close the sky over Ukraine to stop killing children, civilians, destroying Ukrainian memories, and to destroy Ukrainians as a nation. We pray for this to all the conscious world.”

EULAR, the European Alliance of Associations for Rheumatology, said in a statement, “EULAR has stood for peace in Europe and globally, and for improving the lives of people with rheumatic and musculoskeletal diseases, for 75 years. We are committed to the tradition of humanity and peace and are deeply concerned about the general situation of the people in Ukraine. We will do our utmost to contribute to alleviate the suffering. To this end we are urgently exploring options together with other biomedical partners. Please also help to support the people in Ukraine, for example by donating to UNHCR (the UN refugee agency) or ICRC (International Committee of the Red Cross).

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

On the morning of Feb. 24, rheumatologist Olena Garmish woke at 5:50 a.m. from the blasts of rocket fire in Kiev, Ukraine, and saw the explosions through her window

She described that next week to this news organization: air sirens 20 hours a day, fearing death 24 hours a day, and growing food shortages.

Dr. Garmish, executive director of the Association of Rheumatologists of Ukraine, said she continued working at a Kiev hospital until March 4, but then had to leave the country with her children and has traveled to two other countries since. Now she is looking for employment abroad after 22 years as a clinical researcher and practitioner.

omersukrugoksu/Getty Images

“We lost our jobs and rheumatology practice,” she said. Now, she says, she provides online consultations to patients as much as she can.

As air strikes continued Tuesday in Ukraine’s capital city and elsewhere throughout the country, rheumatologists are among citizens forced to upend their personal and professional lives and make the best decisions they can to keep themselves and their families safe.

Roman Yatsyshyn, MD, professor at Ivano-Frankivsk National Medical University in Ivano-Frankivsk, Ukraine, and vice president of the Association of Rheumatologists of Ukraine, told this news organization that many rheumatologists, like Dr. Garmish, have been forced to close their practices and flee the country. The hope is that the moves are temporary, he said.

He said rheumatologists there are having very different experiences depending on their proximity to the shelling.

Dmytro Rekalov, MD, PhD, who has been a practicing rheumatologist for 20 years, said he has had to relocate – he hopes temporarily – to western Ukraine.

He told this news organization that the battles are about 40 km (25 miles) from him.

“I have a small private rheumatology clinic in Zaporizhzhia [in southeastern Ukraine], so if they invade our city, I’ll have to close my clinic and find another place to live and to practice in.” Zaporizhzhia is home to the largest nuclear plant in Europe, a facility that came under attack earlier this month.

Doctors from areas under siege have been forced to move to quieter locations and consult with patients remotely, Dr. Yatsyshyn said.  

“Moreover, all doctors are actively volunteering, helping refugees, and supporting our military at the front,” he said, adding that medications are in short supply.

“We express our sincere gratitude to the world and European medical communities for their help for Ukraine at this time. Medicines and medical devices come to Ukraine from many countries around the world every day,” he said.

Dr. Yatsyshyn said the Ministry of Health of Ukraine is coordinating delivery of medications.

“However, there is still a need for an uninterrupted supply of basic antirheumatic drugs, cytostatics, glucocorticosteroids, analgesics, and nonsteroidal anti-inflammatory drugs. We will be grateful if such help will continue to come from our colleagues,” Dr. Yatsyshyn said.

In most cases, he says, rheumatologists stay in touch with their patients via social media and apps, Skype, and Zoom.

“We have also created professional and patient groups in chat rooms,” he said. “There, we can respond quickly to current issues in different regions. If necessary, we send medicines in case of their absence or danger in certain regions of the country. Rheumatologists have set up a joint group for online counseling and exchange.”

Some rheumatologists have been retrained as emergency physicians, he said. In areas with less military activity, rheumatologists continue to treat patients at their practices. In places where it is relatively calm, rheumatologists consult not only local patients but also migrants from other regions affected by the war, Dr. Yatsyshyn explained.

The Association of Rheumatologists of Ukraine continues its activities, he said.

“We monitor the problems of our colleagues, their relocations, security, and the opportunity to work. In close cooperation with the Ministry of Health, we monitor the provision of necessary medicines to our patients. We are very grateful for the help of our colleagues from European associations, the United States, pharmaceutical companies, medical centers, universities, and volunteer organizations.”

“We have two other big requests to the entire medical and scientific community,” Dr. Yatsyshyn said. “To suspend the membership of all Russian medical communities in European and world associations (including EULAR, EUSTAR, Lupus Academy, ACR, British Society of Rheumatology, and others) with a ban on attending international forums just as almost all sports and art organizations in Europe and the civilized world have done.”

The second request, he said, is “to close the sky over Ukraine to stop killing children, civilians, destroying Ukrainian memories, and to destroy Ukrainians as a nation. We pray for this to all the conscious world.”

EULAR, the European Alliance of Associations for Rheumatology, said in a statement, “EULAR has stood for peace in Europe and globally, and for improving the lives of people with rheumatic and musculoskeletal diseases, for 75 years. We are committed to the tradition of humanity and peace and are deeply concerned about the general situation of the people in Ukraine. We will do our utmost to contribute to alleviate the suffering. To this end we are urgently exploring options together with other biomedical partners. Please also help to support the people in Ukraine, for example by donating to UNHCR (the UN refugee agency) or ICRC (International Committee of the Red Cross).

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

On the morning of Feb. 24, rheumatologist Olena Garmish woke at 5:50 a.m. from the blasts of rocket fire in Kiev, Ukraine, and saw the explosions through her window

She described that next week to this news organization: air sirens 20 hours a day, fearing death 24 hours a day, and growing food shortages.

Dr. Garmish, executive director of the Association of Rheumatologists of Ukraine, said she continued working at a Kiev hospital until March 4, but then had to leave the country with her children and has traveled to two other countries since. Now she is looking for employment abroad after 22 years as a clinical researcher and practitioner.

omersukrugoksu/Getty Images

“We lost our jobs and rheumatology practice,” she said. Now, she says, she provides online consultations to patients as much as she can.

As air strikes continued Tuesday in Ukraine’s capital city and elsewhere throughout the country, rheumatologists are among citizens forced to upend their personal and professional lives and make the best decisions they can to keep themselves and their families safe.

Roman Yatsyshyn, MD, professor at Ivano-Frankivsk National Medical University in Ivano-Frankivsk, Ukraine, and vice president of the Association of Rheumatologists of Ukraine, told this news organization that many rheumatologists, like Dr. Garmish, have been forced to close their practices and flee the country. The hope is that the moves are temporary, he said.

He said rheumatologists there are having very different experiences depending on their proximity to the shelling.

Dmytro Rekalov, MD, PhD, who has been a practicing rheumatologist for 20 years, said he has had to relocate – he hopes temporarily – to western Ukraine.

He told this news organization that the battles are about 40 km (25 miles) from him.

“I have a small private rheumatology clinic in Zaporizhzhia [in southeastern Ukraine], so if they invade our city, I’ll have to close my clinic and find another place to live and to practice in.” Zaporizhzhia is home to the largest nuclear plant in Europe, a facility that came under attack earlier this month.

Doctors from areas under siege have been forced to move to quieter locations and consult with patients remotely, Dr. Yatsyshyn said.  

“Moreover, all doctors are actively volunteering, helping refugees, and supporting our military at the front,” he said, adding that medications are in short supply.

“We express our sincere gratitude to the world and European medical communities for their help for Ukraine at this time. Medicines and medical devices come to Ukraine from many countries around the world every day,” he said.

Dr. Yatsyshyn said the Ministry of Health of Ukraine is coordinating delivery of medications.

“However, there is still a need for an uninterrupted supply of basic antirheumatic drugs, cytostatics, glucocorticosteroids, analgesics, and nonsteroidal anti-inflammatory drugs. We will be grateful if such help will continue to come from our colleagues,” Dr. Yatsyshyn said.

In most cases, he says, rheumatologists stay in touch with their patients via social media and apps, Skype, and Zoom.

“We have also created professional and patient groups in chat rooms,” he said. “There, we can respond quickly to current issues in different regions. If necessary, we send medicines in case of their absence or danger in certain regions of the country. Rheumatologists have set up a joint group for online counseling and exchange.”

Some rheumatologists have been retrained as emergency physicians, he said. In areas with less military activity, rheumatologists continue to treat patients at their practices. In places where it is relatively calm, rheumatologists consult not only local patients but also migrants from other regions affected by the war, Dr. Yatsyshyn explained.

The Association of Rheumatologists of Ukraine continues its activities, he said.

“We monitor the problems of our colleagues, their relocations, security, and the opportunity to work. In close cooperation with the Ministry of Health, we monitor the provision of necessary medicines to our patients. We are very grateful for the help of our colleagues from European associations, the United States, pharmaceutical companies, medical centers, universities, and volunteer organizations.”

“We have two other big requests to the entire medical and scientific community,” Dr. Yatsyshyn said. “To suspend the membership of all Russian medical communities in European and world associations (including EULAR, EUSTAR, Lupus Academy, ACR, British Society of Rheumatology, and others) with a ban on attending international forums just as almost all sports and art organizations in Europe and the civilized world have done.”

The second request, he said, is “to close the sky over Ukraine to stop killing children, civilians, destroying Ukrainian memories, and to destroy Ukrainians as a nation. We pray for this to all the conscious world.”

EULAR, the European Alliance of Associations for Rheumatology, said in a statement, “EULAR has stood for peace in Europe and globally, and for improving the lives of people with rheumatic and musculoskeletal diseases, for 75 years. We are committed to the tradition of humanity and peace and are deeply concerned about the general situation of the people in Ukraine. We will do our utmost to contribute to alleviate the suffering. To this end we are urgently exploring options together with other biomedical partners. Please also help to support the people in Ukraine, for example by donating to UNHCR (the UN refugee agency) or ICRC (International Committee of the Red Cross).

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

“It’s in the computer.”

How many times a week do you hear that?

The advent of the modern EMR has created a new belief in many patients: That all medical office computers are connected, and information from one can be obtained from any of them. So when I ask patients if they had labs, or an MRI, or what their medications are, that’s what I sometimes hear back.

“It’s in the computer.”

True, but not MY computer.

Then they get perplexed, and irritated. Didn’t someone at the other office, or their friends, or something they read online, tell them I’d have access to it? Isn’t all medical info in a giant online database, somewhere, and all doctors can get into it?

Admittedly, I’m probably in better shape than other solo-practice docs. I have access codes to two local radiology places, two large labs, and the largest health care system in my corner of Phoenix. So although I’m not technically a part of them, I can still pull records when I need them for patient care. But if the patient is in my office right then, it takes a minute. My office wifi isn’t the fastest, I have to enter passwords, then do two-factor authentication.

I understand – very much – the importance of the added layers of security, but it adds time to the visit.

Some people, with perhaps more faith in technology than is justified, still don’t understand this. Another doctor sent them to see me, so why don’t I have the results of previous tests and labs? If they tell us what tests they had, and where, and when they make the appointment I can often be prepared for them. But this isn’t consistent.

On the surface some sort of large-scale medical database for everyone sounds good. It would be nice to not have to scramble to get past test results when people come in, and would probably save a lot of money on duplicated labs. But there are legitimate concerns about security and privacy, too.

Not only that, but “it’s in the computer” is also only as good as the people working them. Recently I got a call from an office in a local health care system asking for my notes on a patient. I’d sent them, but they insisted they hadn’t received them. From my desk I logged into their system and found my notes, neatly scanned in and labeled with my name and specialty. When I picked up the phone and told the young lady where to look, she was nice enough to apologize.

I get that. I often overlook things under my own nose, too. But no amount of technology will fix that issue for me or anyone else.

Unfortunately, this misplaced faith in technology doesn’t seem to be going away. People will still keep believing that it works much better than it really does.

That’s human nature, too.

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

“It’s in the computer.”

How many times a week do you hear that?

The advent of the modern EMR has created a new belief in many patients: That all medical office computers are connected, and information from one can be obtained from any of them. So when I ask patients if they had labs, or an MRI, or what their medications are, that’s what I sometimes hear back.

“It’s in the computer.”

True, but not MY computer.

Then they get perplexed, and irritated. Didn’t someone at the other office, or their friends, or something they read online, tell them I’d have access to it? Isn’t all medical info in a giant online database, somewhere, and all doctors can get into it?

Admittedly, I’m probably in better shape than other solo-practice docs. I have access codes to two local radiology places, two large labs, and the largest health care system in my corner of Phoenix. So although I’m not technically a part of them, I can still pull records when I need them for patient care. But if the patient is in my office right then, it takes a minute. My office wifi isn’t the fastest, I have to enter passwords, then do two-factor authentication.

I understand – very much – the importance of the added layers of security, but it adds time to the visit.

Some people, with perhaps more faith in technology than is justified, still don’t understand this. Another doctor sent them to see me, so why don’t I have the results of previous tests and labs? If they tell us what tests they had, and where, and when they make the appointment I can often be prepared for them. But this isn’t consistent.

On the surface some sort of large-scale medical database for everyone sounds good. It would be nice to not have to scramble to get past test results when people come in, and would probably save a lot of money on duplicated labs. But there are legitimate concerns about security and privacy, too.

Not only that, but “it’s in the computer” is also only as good as the people working them. Recently I got a call from an office in a local health care system asking for my notes on a patient. I’d sent them, but they insisted they hadn’t received them. From my desk I logged into their system and found my notes, neatly scanned in and labeled with my name and specialty. When I picked up the phone and told the young lady where to look, she was nice enough to apologize.

I get that. I often overlook things under my own nose, too. But no amount of technology will fix that issue for me or anyone else.

Unfortunately, this misplaced faith in technology doesn’t seem to be going away. People will still keep believing that it works much better than it really does.

That’s human nature, too.

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

“It’s in the computer.”

How many times a week do you hear that?

The advent of the modern EMR has created a new belief in many patients: That all medical office computers are connected, and information from one can be obtained from any of them. So when I ask patients if they had labs, or an MRI, or what their medications are, that’s what I sometimes hear back.

“It’s in the computer.”

True, but not MY computer.

Then they get perplexed, and irritated. Didn’t someone at the other office, or their friends, or something they read online, tell them I’d have access to it? Isn’t all medical info in a giant online database, somewhere, and all doctors can get into it?

Admittedly, I’m probably in better shape than other solo-practice docs. I have access codes to two local radiology places, two large labs, and the largest health care system in my corner of Phoenix. So although I’m not technically a part of them, I can still pull records when I need them for patient care. But if the patient is in my office right then, it takes a minute. My office wifi isn’t the fastest, I have to enter passwords, then do two-factor authentication.

I understand – very much – the importance of the added layers of security, but it adds time to the visit.

Some people, with perhaps more faith in technology than is justified, still don’t understand this. Another doctor sent them to see me, so why don’t I have the results of previous tests and labs? If they tell us what tests they had, and where, and when they make the appointment I can often be prepared for them. But this isn’t consistent.

On the surface some sort of large-scale medical database for everyone sounds good. It would be nice to not have to scramble to get past test results when people come in, and would probably save a lot of money on duplicated labs. But there are legitimate concerns about security and privacy, too.

Not only that, but “it’s in the computer” is also only as good as the people working them. Recently I got a call from an office in a local health care system asking for my notes on a patient. I’d sent them, but they insisted they hadn’t received them. From my desk I logged into their system and found my notes, neatly scanned in and labeled with my name and specialty. When I picked up the phone and told the young lady where to look, she was nice enough to apologize.

I get that. I often overlook things under my own nose, too. But no amount of technology will fix that issue for me or anyone else.

Unfortunately, this misplaced faith in technology doesn’t seem to be going away. People will still keep believing that it works much better than it really does.

That’s human nature, too.

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

When dermatologists are uncertain about a diagnosis, they might seek help from a book or book chapter written by Dirk M. Elston, MD, a past president of the American Academy of Dermatology and the American Society of Dermatopathology who has authored more than 600 peer-reviewed publications and 92 textbook chapters.

After earning his undergraduate degree from Pennsylvania State University and his medical degree from Jefferson Medical College in Philadelphia, Dr. Elston completed an internship and a dermatology residency at Walter Reed Army Medical Center in Washington, as well as a dermatopathology fellowship at the Cleveland Clinic. He currently is professor and chair of the department of dermatology and dermatologic surgery at the Medical University of South Carolina in Charleston.

Dr. Elston is one of five authors of “Andrews’ Diseases of the Skin),” coauthor with Tammie Ferringer, MD, of the “Dermatopathology” textbook, and editor in chief of the Requisites in Dermatology series of textbooks. In 2018, he succeeded Bruce H. Thiers, MD, as editor of the Journal of the American Academy of Dermatology and in 2021, received the AAD’s Gold Medal Award, which is the academy’s highest honor.

In an interview, Dr. Elston reflected on his mentors, shared how he manages his many responsibilities as a clinician, teacher, and editor, and talked about the promising future of dermatology.

Who inspired you most to pursue a career in medicine? My grandmother, Annie Elston, was a physician and dedicated her life to helping others. She was a front-line medic during World War I, helped to run a neonatal syphilis ward after the war, and practiced pediatrics in New York City until her death. She was a great role model.

Did you enter medical school knowing that you wanted to become a dermatologist? If not, what was the turning point for you? I didn’t really know much about dermatology when I entered medical school. I fell in love with the specialty during a rotation.

What was the most memorable experience from your dermatology residency at Walter Reed Army Medical Center? There were so many interesting patients, including many tropical diseases.

Why did you choose to pursue a fellowship in dermatopathology? What was it about this subspeciality that piqued your interest? Great teachers, including Tim Berger, MD, George Lupton, MD, and Dean Pearson, MD. They inspired me to seek a dermpath fellowship and I was lucky enough to train with Wilma Bergfeld, MD.

In your opinion, what’s been the most important advance in dermatopathology to date?

Immunohistochemistry changed the specialty. Now molecular diagnostics is a second wave of major advancement.

How do you stay passionate about both dermatology and dermatopathology? The patients, residents, and fellows keep it interesting. It’s a two-way street. I learn as much as I teach.

You’ve had a remarkable run at the Journal of the American Academy of Dermatology, starting as deputy editor in 2008 before becoming editor in 2018. What’s been most rewarding about this role for you? It is a labor of love and such a privilege to see everyone’s best work.

During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint? Fear of the unknown is always a challenge with a new epidemic and worse with a pandemic. The patients still needed to be seen but it was a challenge with some buildings closed and some personnel afraid to come to work.

Is there anything you would tell your younger self in terms of career advice? Enjoy every step of the journey.

Considering your various work responsibilities as a clinician, teacher, and editor, what’s your strategy for achieving a work-life balance? A good friend of mine is fond of saying that balance is an illusion. There is only resilience. I believe the truth lies somewhere in between. Make time for family, and decide what has to get done today and what can wait until tomorrow.

What development in dermatology are you most excited about in the next 5 years? We are in a golden age of therapeutic innovations that are life changing and lifesaving for our patients. I never would have believed I would see complete cures of patients with widely metastatic melanoma. From psoriasis to eczema to malignancy, our therapeutic armamentarium is dramatically better each year. It makes the practice of medicine exciting.

When dermatologists are uncertain about a diagnosis, they might seek help from a book or book chapter written by Dirk M. Elston, MD, a past president of the American Academy of Dermatology and the American Society of Dermatopathology who has authored more than 600 peer-reviewed publications and 92 textbook chapters.

After earning his undergraduate degree from Pennsylvania State University and his medical degree from Jefferson Medical College in Philadelphia, Dr. Elston completed an internship and a dermatology residency at Walter Reed Army Medical Center in Washington, as well as a dermatopathology fellowship at the Cleveland Clinic. He currently is professor and chair of the department of dermatology and dermatologic surgery at the Medical University of South Carolina in Charleston.

Dr. Elston is one of five authors of “Andrews’ Diseases of the Skin),” coauthor with Tammie Ferringer, MD, of the “Dermatopathology” textbook, and editor in chief of the Requisites in Dermatology series of textbooks. In 2018, he succeeded Bruce H. Thiers, MD, as editor of the Journal of the American Academy of Dermatology and in 2021, received the AAD’s Gold Medal Award, which is the academy’s highest honor.

In an interview, Dr. Elston reflected on his mentors, shared how he manages his many responsibilities as a clinician, teacher, and editor, and talked about the promising future of dermatology.

Who inspired you most to pursue a career in medicine? My grandmother, Annie Elston, was a physician and dedicated her life to helping others. She was a front-line medic during World War I, helped to run a neonatal syphilis ward after the war, and practiced pediatrics in New York City until her death. She was a great role model.

Did you enter medical school knowing that you wanted to become a dermatologist? If not, what was the turning point for you? I didn’t really know much about dermatology when I entered medical school. I fell in love with the specialty during a rotation.

What was the most memorable experience from your dermatology residency at Walter Reed Army Medical Center? There were so many interesting patients, including many tropical diseases.

Why did you choose to pursue a fellowship in dermatopathology? What was it about this subspeciality that piqued your interest? Great teachers, including Tim Berger, MD, George Lupton, MD, and Dean Pearson, MD. They inspired me to seek a dermpath fellowship and I was lucky enough to train with Wilma Bergfeld, MD.

In your opinion, what’s been the most important advance in dermatopathology to date?

Immunohistochemistry changed the specialty. Now molecular diagnostics is a second wave of major advancement.

How do you stay passionate about both dermatology and dermatopathology? The patients, residents, and fellows keep it interesting. It’s a two-way street. I learn as much as I teach.

You’ve had a remarkable run at the Journal of the American Academy of Dermatology, starting as deputy editor in 2008 before becoming editor in 2018. What’s been most rewarding about this role for you? It is a labor of love and such a privilege to see everyone’s best work.

During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint? Fear of the unknown is always a challenge with a new epidemic and worse with a pandemic. The patients still needed to be seen but it was a challenge with some buildings closed and some personnel afraid to come to work.

Is there anything you would tell your younger self in terms of career advice? Enjoy every step of the journey.

Considering your various work responsibilities as a clinician, teacher, and editor, what’s your strategy for achieving a work-life balance? A good friend of mine is fond of saying that balance is an illusion. There is only resilience. I believe the truth lies somewhere in between. Make time for family, and decide what has to get done today and what can wait until tomorrow.

What development in dermatology are you most excited about in the next 5 years? We are in a golden age of therapeutic innovations that are life changing and lifesaving for our patients. I never would have believed I would see complete cures of patients with widely metastatic melanoma. From psoriasis to eczema to malignancy, our therapeutic armamentarium is dramatically better each year. It makes the practice of medicine exciting.

When dermatologists are uncertain about a diagnosis, they might seek help from a book or book chapter written by Dirk M. Elston, MD, a past president of the American Academy of Dermatology and the American Society of Dermatopathology who has authored more than 600 peer-reviewed publications and 92 textbook chapters.

After earning his undergraduate degree from Pennsylvania State University and his medical degree from Jefferson Medical College in Philadelphia, Dr. Elston completed an internship and a dermatology residency at Walter Reed Army Medical Center in Washington, as well as a dermatopathology fellowship at the Cleveland Clinic. He currently is professor and chair of the department of dermatology and dermatologic surgery at the Medical University of South Carolina in Charleston.

Dr. Elston is one of five authors of “Andrews’ Diseases of the Skin),” coauthor with Tammie Ferringer, MD, of the “Dermatopathology” textbook, and editor in chief of the Requisites in Dermatology series of textbooks. In 2018, he succeeded Bruce H. Thiers, MD, as editor of the Journal of the American Academy of Dermatology and in 2021, received the AAD’s Gold Medal Award, which is the academy’s highest honor.

In an interview, Dr. Elston reflected on his mentors, shared how he manages his many responsibilities as a clinician, teacher, and editor, and talked about the promising future of dermatology.

Who inspired you most to pursue a career in medicine? My grandmother, Annie Elston, was a physician and dedicated her life to helping others. She was a front-line medic during World War I, helped to run a neonatal syphilis ward after the war, and practiced pediatrics in New York City until her death. She was a great role model.

Did you enter medical school knowing that you wanted to become a dermatologist? If not, what was the turning point for you? I didn’t really know much about dermatology when I entered medical school. I fell in love with the specialty during a rotation.

What was the most memorable experience from your dermatology residency at Walter Reed Army Medical Center? There were so many interesting patients, including many tropical diseases.

Why did you choose to pursue a fellowship in dermatopathology? What was it about this subspeciality that piqued your interest? Great teachers, including Tim Berger, MD, George Lupton, MD, and Dean Pearson, MD. They inspired me to seek a dermpath fellowship and I was lucky enough to train with Wilma Bergfeld, MD.

In your opinion, what’s been the most important advance in dermatopathology to date?

Immunohistochemistry changed the specialty. Now molecular diagnostics is a second wave of major advancement.

How do you stay passionate about both dermatology and dermatopathology? The patients, residents, and fellows keep it interesting. It’s a two-way street. I learn as much as I teach.

You’ve had a remarkable run at the Journal of the American Academy of Dermatology, starting as deputy editor in 2008 before becoming editor in 2018. What’s been most rewarding about this role for you? It is a labor of love and such a privilege to see everyone’s best work.

During the peak of the COVID-19 pandemic, what were your most significant challenges from both a clinical and a personal standpoint? Fear of the unknown is always a challenge with a new epidemic and worse with a pandemic. The patients still needed to be seen but it was a challenge with some buildings closed and some personnel afraid to come to work.

Is there anything you would tell your younger self in terms of career advice? Enjoy every step of the journey.

Considering your various work responsibilities as a clinician, teacher, and editor, what’s your strategy for achieving a work-life balance? A good friend of mine is fond of saying that balance is an illusion. There is only resilience. I believe the truth lies somewhere in between. Make time for family, and decide what has to get done today and what can wait until tomorrow.

What development in dermatology are you most excited about in the next 5 years? We are in a golden age of therapeutic innovations that are life changing and lifesaving for our patients. I never would have believed I would see complete cures of patients with widely metastatic melanoma. From psoriasis to eczema to malignancy, our therapeutic armamentarium is dramatically better each year. It makes the practice of medicine exciting.

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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