The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration has been trumpeting a huge increase in Food and Drug Administration generic drug approvals during the past 2 years, the result of its actions to streamline a cumbersome process and combat anticompetitive practices. But nearly half of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts.

Kenishirotie/Thinkstock

The administration’s aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower, President Trump noted at a White House event in January 2019. The FDA has approved more than 1,600 generic drug applications since January 2017 – about a third more than it did during the last 2 years of the Obama administration.

But more than 700 generics, or about 43%, still weren’t on the market as of early January, a KHN data analysis of FDA and drug list price records shows. Even more noteworthy: 36% of generics that would be the first to compete against a branded drug are not yet for sale. That means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.

“That’s shockingly high,” said former congressman Henry Waxman, who cosponsored the 1984 law that paved the way for the generic approval process as we know it today. He said he’d like to know more but suspects anticompetitive behavior is at least partly to blame and that revisions to the so-called Hatch-Waxman Act might be needed.

The approved generics that haven’t made it to American medicine cabinets include generic versions of expensive medicines like the blood thinner ticagrelor (Brilinta) and HIV medication emtricitabine/tenofovir disoproxil fumarate (Truvada). They also include six different generic versions of sodium nitroprusside (Nitropress), a heart failure drug, whose price spiked 310% in 2015.

Experts say a variety of factors are to blame. Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them.

“It’s a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb, MD, said in an interview, adding that it will be difficult to solve because it has so many causes. It takes five generics on the market to drive prices down to 33% of the original brand-name price, according to an FDA analysis.

Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10% a year, said Scott Knoer, PharmD, chief pharmacy officer at the Cleveland Clinic. “It makes health care costs go up across the board.”

Even if hospital patients don’t directly see high drug prices in their bills, the higher costs get passed to insurers, who pass them on as higher premiums, Dr. Knoer said. They also get passed to taxpayers, who pay for drugs covered by Medicare and Medicaid.

Consolidation on multiple tiers of the drug supply chain have changed the face of the generic drug market, warping supply and demand.

In some cases, key pharmaceutical ingredients are unavailable or a manufacturer doesn’t have the capacity to launch a product because it’s having difficulty meeting demand for existing products.

Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past 2 years haven’t been brought to market.

Erin Fox, PharmD, a pharmacist at the University of Utah, Salt Lake City, who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” A few generics on the list – like a 10% dextrose injection, to treat patients with low blood sugar – would have been helpful to combat shortages the past few years. “This comes up with shortages a lot – it looks like there are more suppliers than there really are,” Dr. Fox said.

A lot can change between the time a drugmaker files a generic application with the FDA and the time it’s approved.

Some drugmakers that applied for generic approval years ago switched their attention to more profitable products. Novartis, for instance, recently sold a generics division run by Sandoz so Sandoz could focus on other drugs, including biosimilars, which compete with expensive biologic drugs made from living organisms.

“Some of these [generic] drug applications have been sitting 6, 7, 8 years,” said Robert W. Pollock, a former acting deputy director of the FDA’s Office of Generic Drugs who now works for Lachman Consultants. By the time it’s approved, a generic can fall out of favor because patients taking the branded version reported new side effects or because a more-effective branded drug was approved.

For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.” The Federal Trade Commission estimates that such deals cost consumers and taxpayers $3.5 billion a year.

The number of these potentially anticompetitive settlements decreased from fiscal 2014 to fiscal 2015, according to the latest FTC report. Still, Dr. Gottlieb said he hopes to crack down on such tactics. The first generic to take on a branded drug is granted 180 days of exclusivity before the second and third generics can be approved, giving those products a clear advantage.

“We don’t like that companies are able to just park [a generic for] 180 days while they cut a deal not to come to market,” Dr. Gottlieb said, adding that with help from Congress he hopes to force companies to forfeit exclusivity if they don’t launch on time.

In some cases, according to Dr. Gottlieb, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market.

These bundled contracts are secretive, so not much is known about them, but it means companies are filing generic applications just for the option of introducing generics, said health care economist Rena Conti of the Questrom School of Business at Boston University. They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Ms. Conti said. Then they can launch and hike the price.

To be sure, the FDA under Dr. Gottlieb’s leadership has taken steps to increase generic competition, from shaming brand-name drugmakers for blocking generics to publishing documents to help manufacturers win approval more easily. But approval doesn’t necessarily spur competition.

“We used to say it was all about getting in – once you got approval from the FDA, then you could go to market,” said Chip Davis, CEO of the Association for Accessible Medicines, the trade group for makers of generic drugs. The biggest challenges his members face is that there aren’t enough companies purchasing drugs, Mr. Davis said. Consolidation has led to three large buying groups covering 90% of the market, according to a Drug Channels Institute report. So, if you’re the fourth or fifth generic, you may have no one left to sell to.

Yet another barrier relates to how drug middlemen select the drugs they’ll cover under industry formularies, which determine what products insurance plans will cover. In some cases, middlemen known as “pharmacy benefit managers” have made it clear they don’t have room on their formularies for another generic. Or they do, but they give branded drugs preferential treatment with lower copays, hurting the generic’s market share.

Barriers to entry are lower under Gottlieb’s FDA than they’ve been in years past, Conti said, and regulations can help foster competition. But, she said, “they can only do so much.”
 

Methodology

To identify approved drugs that have not reached the market, Kaiser Health News used the FDA’s Orange Book database – as of Jan. 2 – to identify drug applications approved in 2017 or 2018. We then searched the FDA’s online National Drug Code directory for billing codes for the drugs associated with each application as of the same date. To account for a possible lag, we supplemented this list with a more complete billing code directory that we obtained via a Freedom of Information Act request. It includes codes with expected future launch dates that don’t appear in the online version.

According to experts, a billing code doesn’t necessarily mean a drug is on the market. However, every drug on the market needs a list price for reimbursement. We provided a list of application numbers and billing codes to information technology firm Connecture, which then told us whether each one was active, inactive, or had no list price as of Jan. 17.

If an application had at least one billing code with a list price attached, we counted it as on the market, even if other billing codes did not have list prices.

Sometimes, a single generic application can have multiple approval dates. If one of these approval dates occurred in the past 2 years, we included it in our analysis.

To determine whether a drug was a first generic, KHN used the FDA’s 2017 and 2018 lists of first generics as of Jan 2.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

LA JOLLA, CALIF. – A retrospective study suggests patients with mycosis fungoides (MF) have an increased risk of developing hematologic and solid tumor malignancies.

Vidyard Video

Researchers found the risk of second malignancy was highest among MF patients aged 30 to 50 years and patients who had tumor stage or advanced stage MF.

The increased risk was present during the entire period after MF diagnosis, but it was greatest in the first 6 months after diagnosis and roughly a dozen years later.

Amrita Goyal, MD, of the University of Minnesota in Minneapolis, and her colleagues presented these findings at the annual T-cell Lymphoma Forum.

The researchers first assessed the risk of second malignancy in 172 MF patients treated at UMN from 2005 to 2017, comparing this cohort to a control group of 172 patients with seborrheic dermatitis.

Second malignancies occurred in 24 MF patients and three controls, which was a significant difference (P = .0045). The most common second malignancies among the MF patients were melanoma (n = 4), prostate cancer (n = 3), and renal cell carcinoma (n = 3).

Further analyses revealed that MF patients were more likely to develop a second malignancy if they had tumor stage disease (P = .0024) or stage IIB or higher disease (P = .03).

To corroborate and expand upon these results, Dr. Goyal and her colleagues analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database on patients diagnosed with MF from 2000 to 2014.

Among the 6,196 MF patients in this cohort, there were 514 second cancers.

“We found that MF patients were, overall, 10 times more likely to develop a second malignancy [compared with the general population],” Dr. Goyal said.

Specifically, the standardized incidence ratio was 10.15 for all malignancies, 7.33 for solid tumors, and 41.72 for hematologic malignancies.

Standardized incidence ratios for individual malignancies were:

• 69.8 for Hodgkin lymphoma.
• 46.5 for non-Hodgkin lymphoma.
• 8.6 for leukemia.
• 7.2 for melanoma.
• 6.2 for lung cancer.
• 7.9 for female breast cancer.
• 5.2 for colon cancer.
• 4.1 for prostate cancer.
• 3.9 for renal cell carcinoma.
• 3.8 for pancreatic cancer.
• 3.6 for bladder cancer.

“We found there is an increased risk [of second malignancy] during the first 6 months after diagnosis of MF, likely related to patients being in contact with the health care system more,” Dr. Goyal said. “Over time, patients have about a 7- to 10-fold increased risk over baseline, until they reach about 12 or 13 years after diagnosis, at which point, there is an increase in risk.”

The researchers found the greatest risk of second malignancy was among patients aged 30 to 50 years, although there was an increased risk for all age groups.

“The reason we think patients are experiencing an increased risk of cancers is we believe this may be due to immune suppression secondary to the mycosis fungoides, although further studies need to be performed to determine if that’s accurate,” Dr. Goyal said.

To that end, she and her colleagues are planning gene expression studies in patients from the UMN cohort. The researchers plan to examine genes involved in the pathogenesis of second malignancies and MF progression in tissue samples from 36 MF patients, 12 who developed second malignancies and 24 who did not.

The current research was funded by the American Society of Hematology. Dr. Goyal reported having no relevant financial disclosures. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

LA JOLLA, CALIF. – A retrospective study suggests patients with mycosis fungoides (MF) have an increased risk of developing hematologic and solid tumor malignancies.

Vidyard Video

Researchers found the risk of second malignancy was highest among MF patients aged 30 to 50 years and patients who had tumor stage or advanced stage MF.

The increased risk was present during the entire period after MF diagnosis, but it was greatest in the first 6 months after diagnosis and roughly a dozen years later.

Amrita Goyal, MD, of the University of Minnesota in Minneapolis, and her colleagues presented these findings at the annual T-cell Lymphoma Forum.

The researchers first assessed the risk of second malignancy in 172 MF patients treated at UMN from 2005 to 2017, comparing this cohort to a control group of 172 patients with seborrheic dermatitis.

Second malignancies occurred in 24 MF patients and three controls, which was a significant difference (P = .0045). The most common second malignancies among the MF patients were melanoma (n = 4), prostate cancer (n = 3), and renal cell carcinoma (n = 3).

Further analyses revealed that MF patients were more likely to develop a second malignancy if they had tumor stage disease (P = .0024) or stage IIB or higher disease (P = .03).

To corroborate and expand upon these results, Dr. Goyal and her colleagues analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database on patients diagnosed with MF from 2000 to 2014.

Among the 6,196 MF patients in this cohort, there were 514 second cancers.

“We found that MF patients were, overall, 10 times more likely to develop a second malignancy [compared with the general population],” Dr. Goyal said.

Specifically, the standardized incidence ratio was 10.15 for all malignancies, 7.33 for solid tumors, and 41.72 for hematologic malignancies.

Standardized incidence ratios for individual malignancies were:

• 69.8 for Hodgkin lymphoma.
• 46.5 for non-Hodgkin lymphoma.
• 8.6 for leukemia.
• 7.2 for melanoma.
• 6.2 for lung cancer.
• 7.9 for female breast cancer.
• 5.2 for colon cancer.
• 4.1 for prostate cancer.
• 3.9 for renal cell carcinoma.
• 3.8 for pancreatic cancer.
• 3.6 for bladder cancer.

“We found there is an increased risk [of second malignancy] during the first 6 months after diagnosis of MF, likely related to patients being in contact with the health care system more,” Dr. Goyal said. “Over time, patients have about a 7- to 10-fold increased risk over baseline, until they reach about 12 or 13 years after diagnosis, at which point, there is an increase in risk.”

The researchers found the greatest risk of second malignancy was among patients aged 30 to 50 years, although there was an increased risk for all age groups.

“The reason we think patients are experiencing an increased risk of cancers is we believe this may be due to immune suppression secondary to the mycosis fungoides, although further studies need to be performed to determine if that’s accurate,” Dr. Goyal said.

To that end, she and her colleagues are planning gene expression studies in patients from the UMN cohort. The researchers plan to examine genes involved in the pathogenesis of second malignancies and MF progression in tissue samples from 36 MF patients, 12 who developed second malignancies and 24 who did not.

The current research was funded by the American Society of Hematology. Dr. Goyal reported having no relevant financial disclosures. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

LA JOLLA, CALIF. – A retrospective study suggests patients with mycosis fungoides (MF) have an increased risk of developing hematologic and solid tumor malignancies.

Vidyard Video

Researchers found the risk of second malignancy was highest among MF patients aged 30 to 50 years and patients who had tumor stage or advanced stage MF.

The increased risk was present during the entire period after MF diagnosis, but it was greatest in the first 6 months after diagnosis and roughly a dozen years later.

Amrita Goyal, MD, of the University of Minnesota in Minneapolis, and her colleagues presented these findings at the annual T-cell Lymphoma Forum.

The researchers first assessed the risk of second malignancy in 172 MF patients treated at UMN from 2005 to 2017, comparing this cohort to a control group of 172 patients with seborrheic dermatitis.

Second malignancies occurred in 24 MF patients and three controls, which was a significant difference (P = .0045). The most common second malignancies among the MF patients were melanoma (n = 4), prostate cancer (n = 3), and renal cell carcinoma (n = 3).

Further analyses revealed that MF patients were more likely to develop a second malignancy if they had tumor stage disease (P = .0024) or stage IIB or higher disease (P = .03).

To corroborate and expand upon these results, Dr. Goyal and her colleagues analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database on patients diagnosed with MF from 2000 to 2014.

Among the 6,196 MF patients in this cohort, there were 514 second cancers.

“We found that MF patients were, overall, 10 times more likely to develop a second malignancy [compared with the general population],” Dr. Goyal said.

Specifically, the standardized incidence ratio was 10.15 for all malignancies, 7.33 for solid tumors, and 41.72 for hematologic malignancies.

Standardized incidence ratios for individual malignancies were:

• 69.8 for Hodgkin lymphoma.
• 46.5 for non-Hodgkin lymphoma.
• 8.6 for leukemia.
• 7.2 for melanoma.
• 6.2 for lung cancer.
• 7.9 for female breast cancer.
• 5.2 for colon cancer.
• 4.1 for prostate cancer.
• 3.9 for renal cell carcinoma.
• 3.8 for pancreatic cancer.
• 3.6 for bladder cancer.

“We found there is an increased risk [of second malignancy] during the first 6 months after diagnosis of MF, likely related to patients being in contact with the health care system more,” Dr. Goyal said. “Over time, patients have about a 7- to 10-fold increased risk over baseline, until they reach about 12 or 13 years after diagnosis, at which point, there is an increase in risk.”

The researchers found the greatest risk of second malignancy was among patients aged 30 to 50 years, although there was an increased risk for all age groups.

“The reason we think patients are experiencing an increased risk of cancers is we believe this may be due to immune suppression secondary to the mycosis fungoides, although further studies need to be performed to determine if that’s accurate,” Dr. Goyal said.

To that end, she and her colleagues are planning gene expression studies in patients from the UMN cohort. The researchers plan to examine genes involved in the pathogenesis of second malignancies and MF progression in tissue samples from 36 MF patients, 12 who developed second malignancies and 24 who did not.

The current research was funded by the American Society of Hematology. Dr. Goyal reported having no relevant financial disclosures. The T-cell Lymphoma Forum is organized by Jonathan Wood & Associates, which is owned by the same company as this news organization.

jensmith@mdedge.com

Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine.* Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis.

Their aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.

In this episode, Nick Andrews speaks with the two innovators about their motivation to found this organization.

Correction, 3/12/19: An earlier version of this article misstated Kate Gerull's name.

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Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine.* Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis.

Their aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.

In this episode, Nick Andrews speaks with the two innovators about their motivation to found this organization.

Correction, 3/12/19: An earlier version of this article misstated Kate Gerull's name.

Apple Podcasts
Google Podcasts
Spotify

Kate Gerull and Maren Loe founded the non-profit 500 Women in Medicine.* Ms. Gerull and Ms. Loe are third-year medical students at Washington University School of Medicine in St. Louis.

Their aim is to create a network of support and advancement for women in medicine. 500 Women in Medicine is a pod of the organization 500 Women Scientists.

In this episode, Nick Andrews speaks with the two innovators about their motivation to found this organization.

Correction, 3/12/19: An earlier version of this article misstated Kate Gerull's name.

Apple Podcasts
Google Podcasts
Spotify

A plasma proteomic study has identified new biomarkers for Alzheimer’s disease pathology in cognitively unimpaired individuals. Also today, biomarkers predict VTE risk with menopausal oral hormone therapy, there is a cloud of inconsistency hanging over cannabis data, and compounded pain creams are no better than placebo for chronic localized pain.

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A plasma proteomic study has identified new biomarkers for Alzheimer’s disease pathology in cognitively unimpaired individuals. Also today, biomarkers predict VTE risk with menopausal oral hormone therapy, there is a cloud of inconsistency hanging over cannabis data, and compounded pain creams are no better than placebo for chronic localized pain.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

A plasma proteomic study has identified new biomarkers for Alzheimer’s disease pathology in cognitively unimpaired individuals. Also today, biomarkers predict VTE risk with menopausal oral hormone therapy, there is a cloud of inconsistency hanging over cannabis data, and compounded pain creams are no better than placebo for chronic localized pain.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Even though peripheral artery disease (PAD) is almost 3 times more prevalent among African Americans compared with that of whites, it is understudied, say researchers from University of Mississippi. They say earlier studies did not include significant numbers of African Americans, limiting the ability to single out the effects of smoking in African Americans as distinct from, for example, diabetes mellitus, hypertension, and obesity.

This National Institute of Health (NIH)-funded study, however, provides some new information about what raises the risks of PAD in African Americans. The researchers studied participants in the Jackson Heart Study, the largest single-site cohort study investigating cardiovascular disease in African Americans.

They divided 5,258 participants into 3 groups: smokers, past smokers, never smokers. After taking other risk factors into account, they found people who smoked > 1 pack a day had a significantly higher risk than did those smoking < 19 cigarettes a day. A longer history of smoking also raised the risk of PAD.

Their findings point to the benefits of stopping smoking, the researchers say: Although never smokers had the lowest risk, past smokers also had lower odds.

The researchers caution, though, that despite strong associations between smoking and PAD, their findings do not establish a causal link.

Even though peripheral artery disease (PAD) is almost 3 times more prevalent among African Americans compared with that of whites, it is understudied, say researchers from University of Mississippi. They say earlier studies did not include significant numbers of African Americans, limiting the ability to single out the effects of smoking in African Americans as distinct from, for example, diabetes mellitus, hypertension, and obesity.

This National Institute of Health (NIH)-funded study, however, provides some new information about what raises the risks of PAD in African Americans. The researchers studied participants in the Jackson Heart Study, the largest single-site cohort study investigating cardiovascular disease in African Americans.

They divided 5,258 participants into 3 groups: smokers, past smokers, never smokers. After taking other risk factors into account, they found people who smoked > 1 pack a day had a significantly higher risk than did those smoking < 19 cigarettes a day. A longer history of smoking also raised the risk of PAD.

Their findings point to the benefits of stopping smoking, the researchers say: Although never smokers had the lowest risk, past smokers also had lower odds.

The researchers caution, though, that despite strong associations between smoking and PAD, their findings do not establish a causal link.

Even though peripheral artery disease (PAD) is almost 3 times more prevalent among African Americans compared with that of whites, it is understudied, say researchers from University of Mississippi. They say earlier studies did not include significant numbers of African Americans, limiting the ability to single out the effects of smoking in African Americans as distinct from, for example, diabetes mellitus, hypertension, and obesity.

This National Institute of Health (NIH)-funded study, however, provides some new information about what raises the risks of PAD in African Americans. The researchers studied participants in the Jackson Heart Study, the largest single-site cohort study investigating cardiovascular disease in African Americans.

They divided 5,258 participants into 3 groups: smokers, past smokers, never smokers. After taking other risk factors into account, they found people who smoked > 1 pack a day had a significantly higher risk than did those smoking < 19 cigarettes a day. A longer history of smoking also raised the risk of PAD.

Their findings point to the benefits of stopping smoking, the researchers say: Although never smokers had the lowest risk, past smokers also had lower odds.

The researchers caution, though, that despite strong associations between smoking and PAD, their findings do not establish a causal link.

SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.

Bruce Jancin/MDedge News

“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.

All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.

EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.

In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.

Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.

Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).

Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.


 

What the latest guidelines say

The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.

The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
 

Who will take the lead in this new treatment strategy?

Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.

“Cardiologists need to take a more active role,” he declared.

“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”

As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.

“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.

Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.

bjancin@mdedge.com

SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.

Bruce Jancin/MDedge News

“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.

All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.

EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.

In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.

Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.

Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).

Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.


 

What the latest guidelines say

The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.

The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
 

Who will take the lead in this new treatment strategy?

Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.

“Cardiologists need to take a more active role,” he declared.

“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”

As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.

“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.

Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.

bjancin@mdedge.com

SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.

Bruce Jancin/MDedge News

“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.

All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.

EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.

In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.

Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.

Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).

Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.


 

What the latest guidelines say

The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.

The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
 

Who will take the lead in this new treatment strategy?

Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.

“Cardiologists need to take a more active role,” he declared.

“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”

As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.

“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.

Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.

bjancin@mdedge.com

Almost all pregnant women would want information about serious treatable childhood-onset conditions from noninvasive prenatal whole-genome sequencing, according to results from a survey published in Obstetrics & Gynecology.

Stuart Jenner/Thinkstock

Nearly half said they would want clear guidance from clinicians before undergoing the noninvasive procedure.

“Prenatal whole-genome sequencing offers significantly more fetal information than women can currently receive, and it is not surprising that, when faced with a tremendous range of information, many women want recommendations from their clinicians,” Haley K. Sullivan from the National Institutes of Health Clinical Center and National Human Genome Research Institute and colleagues wrote. “Our data suggest that most women prefer a directive interaction with their clinician when deciding what types of genetic information to receive from prenatal whole-genome sequencing.”

Research coordinators from the Inova Translational Medicine Institute offered 805 pregnant women a survey on their preferences for prenatal whole-genome sequencing between June and August 2017; of these, 553 women answered (69% response rate). The women responded to questions about what type of information they would like to receive if they were to undergo prenatal whole-genome sequencing and what role a clinician would preferably play in the decision-making process. The researchers divided the survey into sections based on actionability, severity, prevalence, and age of onset.

According to the survey results, 90% of respondents wanted information on serious treatable childhood-onset diseases from prenatal whole-genome sequencing results, while 40% said they did not want to receive results based on nonmedical traits such as eye color, height, or athletic ability.

With regard to clinician role, 45% of women said they wanted all options presented with clear recommendations from a clinician on which tests to order, 26% wanted all options presented but with a joint decision-making process, 13% wanted all options presented but independent decision making, and 11% wanted the clear recommendation from clinicians alone.

The respondents said the most common reason for wanting to undergo prenatal whole-genome sequencing was to prepare “financially, medically, or psychologically” for a child with special needs, the researchers said.

“This represents a departure from the current state of genetic counseling, where nondirectiveness is a central tenet, and is contrary to the 45% of ob.gyns. who said in a previous survey that they should not be at all directive when counseling patients on prenatal whole-genome sequencing,” the authors wrote. “Given this clear patient desire for guidance, there is a vital opportunity for the American College of Obstetricians and Gynecologists to provide leadership and recommendations as prenatal whole-genome sequencing is adopted into clinical practice.”

Limitations in the study include asking the respondents to make hypothetical decisions, using examples to describe genetic conditions that might have skewed decision making; asking women to pick only one reason for wanting the sequencing information from a list of predetermined options, when many reasons may be important to them; social desirability bias in the responses, if women are reluctant to pick a choice they perceive as less socially acceptable; and a potential systematic difference between women who were and were not enrolled as survey participants. The respondents also were from the Northern Virginia area, which may not be generalizable to a national population of patients, the researchers said.

This study was supported by the Intramural Research Program of the National Human Genome Research Institute and the Clinical Center Department of Bioethics, National Institutes of Health. The authors reported no relevant conflicts of interest.

SOURCE: Sullivan HK et al. Obstet Gynecol. 2019 Mar. doi: 10.1097/AOG.0000000000003121.

Almost all pregnant women would want information about serious treatable childhood-onset conditions from noninvasive prenatal whole-genome sequencing, according to results from a survey published in Obstetrics & Gynecology.

Stuart Jenner/Thinkstock

Nearly half said they would want clear guidance from clinicians before undergoing the noninvasive procedure.

“Prenatal whole-genome sequencing offers significantly more fetal information than women can currently receive, and it is not surprising that, when faced with a tremendous range of information, many women want recommendations from their clinicians,” Haley K. Sullivan from the National Institutes of Health Clinical Center and National Human Genome Research Institute and colleagues wrote. “Our data suggest that most women prefer a directive interaction with their clinician when deciding what types of genetic information to receive from prenatal whole-genome sequencing.”

Research coordinators from the Inova Translational Medicine Institute offered 805 pregnant women a survey on their preferences for prenatal whole-genome sequencing between June and August 2017; of these, 553 women answered (69% response rate). The women responded to questions about what type of information they would like to receive if they were to undergo prenatal whole-genome sequencing and what role a clinician would preferably play in the decision-making process. The researchers divided the survey into sections based on actionability, severity, prevalence, and age of onset.

According to the survey results, 90% of respondents wanted information on serious treatable childhood-onset diseases from prenatal whole-genome sequencing results, while 40% said they did not want to receive results based on nonmedical traits such as eye color, height, or athletic ability.

With regard to clinician role, 45% of women said they wanted all options presented with clear recommendations from a clinician on which tests to order, 26% wanted all options presented but with a joint decision-making process, 13% wanted all options presented but independent decision making, and 11% wanted the clear recommendation from clinicians alone.

The respondents said the most common reason for wanting to undergo prenatal whole-genome sequencing was to prepare “financially, medically, or psychologically” for a child with special needs, the researchers said.

“This represents a departure from the current state of genetic counseling, where nondirectiveness is a central tenet, and is contrary to the 45% of ob.gyns. who said in a previous survey that they should not be at all directive when counseling patients on prenatal whole-genome sequencing,” the authors wrote. “Given this clear patient desire for guidance, there is a vital opportunity for the American College of Obstetricians and Gynecologists to provide leadership and recommendations as prenatal whole-genome sequencing is adopted into clinical practice.”

Limitations in the study include asking the respondents to make hypothetical decisions, using examples to describe genetic conditions that might have skewed decision making; asking women to pick only one reason for wanting the sequencing information from a list of predetermined options, when many reasons may be important to them; social desirability bias in the responses, if women are reluctant to pick a choice they perceive as less socially acceptable; and a potential systematic difference between women who were and were not enrolled as survey participants. The respondents also were from the Northern Virginia area, which may not be generalizable to a national population of patients, the researchers said.

This study was supported by the Intramural Research Program of the National Human Genome Research Institute and the Clinical Center Department of Bioethics, National Institutes of Health. The authors reported no relevant conflicts of interest.

SOURCE: Sullivan HK et al. Obstet Gynecol. 2019 Mar. doi: 10.1097/AOG.0000000000003121.

Almost all pregnant women would want information about serious treatable childhood-onset conditions from noninvasive prenatal whole-genome sequencing, according to results from a survey published in Obstetrics & Gynecology.

Stuart Jenner/Thinkstock

Nearly half said they would want clear guidance from clinicians before undergoing the noninvasive procedure.

“Prenatal whole-genome sequencing offers significantly more fetal information than women can currently receive, and it is not surprising that, when faced with a tremendous range of information, many women want recommendations from their clinicians,” Haley K. Sullivan from the National Institutes of Health Clinical Center and National Human Genome Research Institute and colleagues wrote. “Our data suggest that most women prefer a directive interaction with their clinician when deciding what types of genetic information to receive from prenatal whole-genome sequencing.”

Research coordinators from the Inova Translational Medicine Institute offered 805 pregnant women a survey on their preferences for prenatal whole-genome sequencing between June and August 2017; of these, 553 women answered (69% response rate). The women responded to questions about what type of information they would like to receive if they were to undergo prenatal whole-genome sequencing and what role a clinician would preferably play in the decision-making process. The researchers divided the survey into sections based on actionability, severity, prevalence, and age of onset.

According to the survey results, 90% of respondents wanted information on serious treatable childhood-onset diseases from prenatal whole-genome sequencing results, while 40% said they did not want to receive results based on nonmedical traits such as eye color, height, or athletic ability.

With regard to clinician role, 45% of women said they wanted all options presented with clear recommendations from a clinician on which tests to order, 26% wanted all options presented but with a joint decision-making process, 13% wanted all options presented but independent decision making, and 11% wanted the clear recommendation from clinicians alone.

The respondents said the most common reason for wanting to undergo prenatal whole-genome sequencing was to prepare “financially, medically, or psychologically” for a child with special needs, the researchers said.

“This represents a departure from the current state of genetic counseling, where nondirectiveness is a central tenet, and is contrary to the 45% of ob.gyns. who said in a previous survey that they should not be at all directive when counseling patients on prenatal whole-genome sequencing,” the authors wrote. “Given this clear patient desire for guidance, there is a vital opportunity for the American College of Obstetricians and Gynecologists to provide leadership and recommendations as prenatal whole-genome sequencing is adopted into clinical practice.”

Limitations in the study include asking the respondents to make hypothetical decisions, using examples to describe genetic conditions that might have skewed decision making; asking women to pick only one reason for wanting the sequencing information from a list of predetermined options, when many reasons may be important to them; social desirability bias in the responses, if women are reluctant to pick a choice they perceive as less socially acceptable; and a potential systematic difference between women who were and were not enrolled as survey participants. The respondents also were from the Northern Virginia area, which may not be generalizable to a national population of patients, the researchers said.

This study was supported by the Intramural Research Program of the National Human Genome Research Institute and the Clinical Center Department of Bioethics, National Institutes of Health. The authors reported no relevant conflicts of interest.

SOURCE: Sullivan HK et al. Obstet Gynecol. 2019 Mar. doi: 10.1097/AOG.0000000000003121.

If Republican state attorneys general prevail in their legal bid to overturn the Affordable Care Act, patients with preexisting conditions will lose their coverage protections, and an additional 24 million Americans could become uninsured, according to testimony presented at a Feb. 6 hearing of the House Energy and Commerce Health Subcommittee.

Courtesy Ways &amp; Means Health Subcommittee

A ruling for the plaintiffs in Texas v. United States also would mean the ACA’s consumer protections for employer-based coverage would be eliminated, affecting more than 150 million Americans, said Christen Linke Young, an attorney and fellow for the liberal-leaning USC-Brookings Schaeffer Initiative on Health Policy.

“The ACA’s changes to Medicare would be undone, reinstating copays on preventive services and reopening the prescription drug ‘donut hole,’ ” Ms. Young testified at the hearing. “It would also create major confusion in Medicare payment, as the ACA policies that are today fully integrated into the Medicare payment rules would suddenly lack a legislative basis.”

Ms. Linke Young was one of five witnesses who testified before lawmakers about the implications of Texas v. United States, an ongoing legal case that centers on whether a part of the health care law should be severed and if so, whether the entire law should then fall.

A group of Republican state attorneys general sued over the law in 2018, arguing that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. The attorneys general also argue that, if the mandate is severed, the entire ACA should be struck down.

In response to the suit, the Trump administration agreed that the mandate is unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. The remainder of the ACA can stand without the three linked provisions, according to the Trump administration, which refused to defend the case.

A coalition of 17 Democratic attorneys general have stepped in to defend the case.

In December, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. In January, the circuit court froze the case in light of the federal government’s partial shutdown. The case remains on hold.

At the hearing, Thomas P. Miller, a resident fellow at the conservative-leaning American Enterprise Institute, testified that a 5th Circuit decision would not likely come before summer 2019, followed by a potential U.S. Supreme Court reading in 2020 – if the case gets that far.

“The probability of a Supreme Court ruling that would overturn the entire ACA remains very low, despite last December’s decision at the federal district court level reaching exactly that legal conclusion,” Mr. Miller testified. “Given the murkiness of divining legislative intent in harder cases like the ACA, challenges to the individual mandate, past and present, it’s better to conclude that, although several different severability settings are hypothetically conceivable, it remains all but certain that an ultimate Supreme Court ruling in this case will, at a minimum, follow its previous inclinations revealed in the 2012 and 2015 ACA challenges and try to save as much of the law as possible.”

If the individual mandate is ultimately severed from the ACA, the decision would have little impact on beneficiaries or function of the health care law, according to Simon Lazarus, a lawyer and writer on constitutional and legal issues.

“Such a result will have virtually no impact on the operation of the ACA, nor on the millions of Americans – in reality, substantially all Americans – who depend on the ACA and its guarantees for people with preexisting conditions and myriad other protections that now are ‘baked into’ the national health care system,” Mr. Lazarus testified at the hearing. “To declare invalid the law’s shared responsibility payment provision, when that provision has no financial penalty behind it, will, by itself, have little if any depressive effect on the number of enrollees in health insurance plans.”

However, Mr. Lazarus noted that the guaranteed issue and community rating provisions of the law are “critical protections” for people with preexisting conditions.

Avik Roy, president for the Foundation for Research on Equal Opportunity, a nonpartisan organization that supports universal health care, testified that the Trump administration’s position about the mandate being tied to the guaranteed issue and community rating provisions is being mischaracterized as implying the administration opposes protecting people with preexisting conditions. President Trump has repeatedly expressed that any reforms or replacements of the ACA cover those with preexisting conditions, he said.

Mr. Roy recommended that Congress pass a bill reiterating the guaranteed issue and community rating requirements in the individual market to ensure protection for patients with preexisting conditions in light of Texas v. United States.

“I understand that a motion to produce such legislation was proposed by House Republicans during floor debate at the beginning of this Congress, [a bill] that would guarantee that no American could be denied coverage, or be charged higher premiums or cost sharing, as a result of a previous or current illness – and that the motion was defeated by the majority,” Mr. Roy testified. To me, this is a shame, as such legislation would ensure that Americans with preexisting conditions would be protected whatever the courts decide. I hope that Congress will reconsider its position.”

A number of subcommittee members pledged their support for protecting people with preexisting conditions and encouraged discussion of further legislation proposals.

“Let me speak on behalf of Republicans; we fully support protecting Americans with preexisting conditions,” said Rep. Greg Walden (R-Ore.), ranking member of the full committee. “We’ve said this repeatedly, we’ve acted accordingly, and we mean it completely. We could and should inject certainly into the system by passing legislation to protect those with preexisting conditions.”

Rep. Michael Burgess, MD, (R-Texas) questioned why the subcommittee was having a hearing on Texas v. United States, rather than focusing on making specific health policy improvements.

“It’s unfortunate we’re having a hearing that doesn’t move toward the development of any policies that will actually improve health care for Americans,” Rep. Burgess said during the hearing. “To that effect, there are numerous options that you could bring before us that could moot [Texas v. United States], but the subcommittee apparently has chosen not to do so.”

Committee Chairman Frank Pallone Jr. (D-N.J.), who called for the hearing, took offense at Rep. Burgess’ statements, expressing the importance of the hearing and the case at large.

“I saw no effort at all in the time that you were the chairman [of the health subcommittee] to try to work toward solutions in improving the ACA,” Rep. Pallone said. “What I saw were constant efforts to join with President Trump to sabotage it. ... and the reason that this hearing is so important is because the ultimate sabotage would be to have the courts rule that the ACA was unconstitutional, which is totally bogus.”

The Subcommittee on Health will hold another hearing on Feb. 13 to discuss ACA legislation and protections for patients with preexisting conditions.

agallegos@mdedge.com

If Republican state attorneys general prevail in their legal bid to overturn the Affordable Care Act, patients with preexisting conditions will lose their coverage protections, and an additional 24 million Americans could become uninsured, according to testimony presented at a Feb. 6 hearing of the House Energy and Commerce Health Subcommittee.

Courtesy Ways &amp; Means Health Subcommittee

A ruling for the plaintiffs in Texas v. United States also would mean the ACA’s consumer protections for employer-based coverage would be eliminated, affecting more than 150 million Americans, said Christen Linke Young, an attorney and fellow for the liberal-leaning USC-Brookings Schaeffer Initiative on Health Policy.

“The ACA’s changes to Medicare would be undone, reinstating copays on preventive services and reopening the prescription drug ‘donut hole,’ ” Ms. Young testified at the hearing. “It would also create major confusion in Medicare payment, as the ACA policies that are today fully integrated into the Medicare payment rules would suddenly lack a legislative basis.”

Ms. Linke Young was one of five witnesses who testified before lawmakers about the implications of Texas v. United States, an ongoing legal case that centers on whether a part of the health care law should be severed and if so, whether the entire law should then fall.

A group of Republican state attorneys general sued over the law in 2018, arguing that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. The attorneys general also argue that, if the mandate is severed, the entire ACA should be struck down.

In response to the suit, the Trump administration agreed that the mandate is unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. The remainder of the ACA can stand without the three linked provisions, according to the Trump administration, which refused to defend the case.

A coalition of 17 Democratic attorneys general have stepped in to defend the case.

In December, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. In January, the circuit court froze the case in light of the federal government’s partial shutdown. The case remains on hold.

At the hearing, Thomas P. Miller, a resident fellow at the conservative-leaning American Enterprise Institute, testified that a 5th Circuit decision would not likely come before summer 2019, followed by a potential U.S. Supreme Court reading in 2020 – if the case gets that far.

“The probability of a Supreme Court ruling that would overturn the entire ACA remains very low, despite last December’s decision at the federal district court level reaching exactly that legal conclusion,” Mr. Miller testified. “Given the murkiness of divining legislative intent in harder cases like the ACA, challenges to the individual mandate, past and present, it’s better to conclude that, although several different severability settings are hypothetically conceivable, it remains all but certain that an ultimate Supreme Court ruling in this case will, at a minimum, follow its previous inclinations revealed in the 2012 and 2015 ACA challenges and try to save as much of the law as possible.”

If the individual mandate is ultimately severed from the ACA, the decision would have little impact on beneficiaries or function of the health care law, according to Simon Lazarus, a lawyer and writer on constitutional and legal issues.

“Such a result will have virtually no impact on the operation of the ACA, nor on the millions of Americans – in reality, substantially all Americans – who depend on the ACA and its guarantees for people with preexisting conditions and myriad other protections that now are ‘baked into’ the national health care system,” Mr. Lazarus testified at the hearing. “To declare invalid the law’s shared responsibility payment provision, when that provision has no financial penalty behind it, will, by itself, have little if any depressive effect on the number of enrollees in health insurance plans.”

However, Mr. Lazarus noted that the guaranteed issue and community rating provisions of the law are “critical protections” for people with preexisting conditions.

Avik Roy, president for the Foundation for Research on Equal Opportunity, a nonpartisan organization that supports universal health care, testified that the Trump administration’s position about the mandate being tied to the guaranteed issue and community rating provisions is being mischaracterized as implying the administration opposes protecting people with preexisting conditions. President Trump has repeatedly expressed that any reforms or replacements of the ACA cover those with preexisting conditions, he said.

Mr. Roy recommended that Congress pass a bill reiterating the guaranteed issue and community rating requirements in the individual market to ensure protection for patients with preexisting conditions in light of Texas v. United States.

“I understand that a motion to produce such legislation was proposed by House Republicans during floor debate at the beginning of this Congress, [a bill] that would guarantee that no American could be denied coverage, or be charged higher premiums or cost sharing, as a result of a previous or current illness – and that the motion was defeated by the majority,” Mr. Roy testified. To me, this is a shame, as such legislation would ensure that Americans with preexisting conditions would be protected whatever the courts decide. I hope that Congress will reconsider its position.”

A number of subcommittee members pledged their support for protecting people with preexisting conditions and encouraged discussion of further legislation proposals.

“Let me speak on behalf of Republicans; we fully support protecting Americans with preexisting conditions,” said Rep. Greg Walden (R-Ore.), ranking member of the full committee. “We’ve said this repeatedly, we’ve acted accordingly, and we mean it completely. We could and should inject certainly into the system by passing legislation to protect those with preexisting conditions.”

Rep. Michael Burgess, MD, (R-Texas) questioned why the subcommittee was having a hearing on Texas v. United States, rather than focusing on making specific health policy improvements.

“It’s unfortunate we’re having a hearing that doesn’t move toward the development of any policies that will actually improve health care for Americans,” Rep. Burgess said during the hearing. “To that effect, there are numerous options that you could bring before us that could moot [Texas v. United States], but the subcommittee apparently has chosen not to do so.”

Committee Chairman Frank Pallone Jr. (D-N.J.), who called for the hearing, took offense at Rep. Burgess’ statements, expressing the importance of the hearing and the case at large.

“I saw no effort at all in the time that you were the chairman [of the health subcommittee] to try to work toward solutions in improving the ACA,” Rep. Pallone said. “What I saw were constant efforts to join with President Trump to sabotage it. ... and the reason that this hearing is so important is because the ultimate sabotage would be to have the courts rule that the ACA was unconstitutional, which is totally bogus.”

The Subcommittee on Health will hold another hearing on Feb. 13 to discuss ACA legislation and protections for patients with preexisting conditions.

agallegos@mdedge.com

If Republican state attorneys general prevail in their legal bid to overturn the Affordable Care Act, patients with preexisting conditions will lose their coverage protections, and an additional 24 million Americans could become uninsured, according to testimony presented at a Feb. 6 hearing of the House Energy and Commerce Health Subcommittee.

Courtesy Ways &amp; Means Health Subcommittee

A ruling for the plaintiffs in Texas v. United States also would mean the ACA’s consumer protections for employer-based coverage would be eliminated, affecting more than 150 million Americans, said Christen Linke Young, an attorney and fellow for the liberal-leaning USC-Brookings Schaeffer Initiative on Health Policy.

“The ACA’s changes to Medicare would be undone, reinstating copays on preventive services and reopening the prescription drug ‘donut hole,’ ” Ms. Young testified at the hearing. “It would also create major confusion in Medicare payment, as the ACA policies that are today fully integrated into the Medicare payment rules would suddenly lack a legislative basis.”

Ms. Linke Young was one of five witnesses who testified before lawmakers about the implications of Texas v. United States, an ongoing legal case that centers on whether a part of the health care law should be severed and if so, whether the entire law should then fall.

A group of Republican state attorneys general sued over the law in 2018, arguing that, because budget legislation in 2017 zeroed out the penalties associated with the ACA’s individual mandate, the mandate is invalid. The attorneys general also argue that, if the mandate is severed, the entire ACA should be struck down.

In response to the suit, the Trump administration agreed that the mandate is unconstitutional and should be parsed. Attorneys for the administration wrote that, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. Guaranteed issue refers to insurers in the individual market offering coverage to all citizens, regardless of preexisting conditions, while community rating refers to charging equal premiums to every patient, no matter their past health status. The remainder of the ACA can stand without the three linked provisions, according to the Trump administration, which refused to defend the case.

A coalition of 17 Democratic attorneys general have stepped in to defend the case.

In December, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th Circuit by the Democratic attorneys general. In January, the circuit court froze the case in light of the federal government’s partial shutdown. The case remains on hold.

At the hearing, Thomas P. Miller, a resident fellow at the conservative-leaning American Enterprise Institute, testified that a 5th Circuit decision would not likely come before summer 2019, followed by a potential U.S. Supreme Court reading in 2020 – if the case gets that far.

“The probability of a Supreme Court ruling that would overturn the entire ACA remains very low, despite last December’s decision at the federal district court level reaching exactly that legal conclusion,” Mr. Miller testified. “Given the murkiness of divining legislative intent in harder cases like the ACA, challenges to the individual mandate, past and present, it’s better to conclude that, although several different severability settings are hypothetically conceivable, it remains all but certain that an ultimate Supreme Court ruling in this case will, at a minimum, follow its previous inclinations revealed in the 2012 and 2015 ACA challenges and try to save as much of the law as possible.”

If the individual mandate is ultimately severed from the ACA, the decision would have little impact on beneficiaries or function of the health care law, according to Simon Lazarus, a lawyer and writer on constitutional and legal issues.

“Such a result will have virtually no impact on the operation of the ACA, nor on the millions of Americans – in reality, substantially all Americans – who depend on the ACA and its guarantees for people with preexisting conditions and myriad other protections that now are ‘baked into’ the national health care system,” Mr. Lazarus testified at the hearing. “To declare invalid the law’s shared responsibility payment provision, when that provision has no financial penalty behind it, will, by itself, have little if any depressive effect on the number of enrollees in health insurance plans.”

However, Mr. Lazarus noted that the guaranteed issue and community rating provisions of the law are “critical protections” for people with preexisting conditions.

Avik Roy, president for the Foundation for Research on Equal Opportunity, a nonpartisan organization that supports universal health care, testified that the Trump administration’s position about the mandate being tied to the guaranteed issue and community rating provisions is being mischaracterized as implying the administration opposes protecting people with preexisting conditions. President Trump has repeatedly expressed that any reforms or replacements of the ACA cover those with preexisting conditions, he said.

Mr. Roy recommended that Congress pass a bill reiterating the guaranteed issue and community rating requirements in the individual market to ensure protection for patients with preexisting conditions in light of Texas v. United States.

“I understand that a motion to produce such legislation was proposed by House Republicans during floor debate at the beginning of this Congress, [a bill] that would guarantee that no American could be denied coverage, or be charged higher premiums or cost sharing, as a result of a previous or current illness – and that the motion was defeated by the majority,” Mr. Roy testified. To me, this is a shame, as such legislation would ensure that Americans with preexisting conditions would be protected whatever the courts decide. I hope that Congress will reconsider its position.”

A number of subcommittee members pledged their support for protecting people with preexisting conditions and encouraged discussion of further legislation proposals.

“Let me speak on behalf of Republicans; we fully support protecting Americans with preexisting conditions,” said Rep. Greg Walden (R-Ore.), ranking member of the full committee. “We’ve said this repeatedly, we’ve acted accordingly, and we mean it completely. We could and should inject certainly into the system by passing legislation to protect those with preexisting conditions.”

Rep. Michael Burgess, MD, (R-Texas) questioned why the subcommittee was having a hearing on Texas v. United States, rather than focusing on making specific health policy improvements.

“It’s unfortunate we’re having a hearing that doesn’t move toward the development of any policies that will actually improve health care for Americans,” Rep. Burgess said during the hearing. “To that effect, there are numerous options that you could bring before us that could moot [Texas v. United States], but the subcommittee apparently has chosen not to do so.”

Committee Chairman Frank Pallone Jr. (D-N.J.), who called for the hearing, took offense at Rep. Burgess’ statements, expressing the importance of the hearing and the case at large.

“I saw no effort at all in the time that you were the chairman [of the health subcommittee] to try to work toward solutions in improving the ACA,” Rep. Pallone said. “What I saw were constant efforts to join with President Trump to sabotage it. ... and the reason that this hearing is so important is because the ultimate sabotage would be to have the courts rule that the ACA was unconstitutional, which is totally bogus.”

The Subcommittee on Health will hold another hearing on Feb. 13 to discuss ACA legislation and protections for patients with preexisting conditions.

agallegos@mdedge.com

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

sworcester@mdedge.com

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

sworcester@mdedge.com

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

sworcester@mdedge.com

Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.

Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.

Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.

“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.

“We’re just happy that we’re prepared and that there is vaccine available.”

copyright DesignPics/Thinkstock

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.

Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.

Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.

“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.

“We’re just happy that we’re prepared and that there is vaccine available.”

copyright DesignPics/Thinkstock

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.

Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.

Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.

“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.

“We’re just happy that we’re prepared and that there is vaccine available.”

copyright DesignPics/Thinkstock

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.