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Don’t panic over lamotrigine, but beware of cardiac risks
New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.
“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”
In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”
The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”
Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”
As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.
But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
Special precautions
So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.
- Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
- “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
- Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
- “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
- “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”
Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”
For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.
Dr. French reported no disclosures.
New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.
“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”
In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”
The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”
Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”
As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.
But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
Special precautions
So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.
- Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
- “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
- Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
- “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
- “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”
Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”
For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.
Dr. French reported no disclosures.
New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.
“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”
In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”
The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”
Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”
As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.
But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
Special precautions
So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.
- Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
- “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
- Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
- “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
- “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”
Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”
For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.
Dr. French reported no disclosures.
FROM AES 2021
CDC panel backs mRNA COVID vaccines over J&J because of clot risk
because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.
In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.
The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.
The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said
Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.
In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.
For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.
The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.
About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.
A version of this article first appeared on WebMD.com.
because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.
In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.
The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.
The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said
Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.
In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.
For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.
The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.
About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.
A version of this article first appeared on WebMD.com.
because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.
In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.
The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.
The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said
Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.
In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.
For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.
The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.
About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.
A version of this article first appeared on WebMD.com.
Califf plans work on opioids, accelerated approvals on return to FDA
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
Outrage over dapagliflozin withdrawal for type 1 diabetes in EU
In a shocking, yet low-key, announcement, the sodium-glucose transporter 2 (SGLT2) inhibitor dapagliflozin (Forxiga, AstraZeneca) has been withdrawn from the market in all EU countries for the indication of type 1 diabetes.
This includes withdrawal in the U.K., which was part of the EU when dapagliflozin was approved for type 1 diabetes in 2019, but following Brexit, is no longer.
AstraZeneca said the decision is not motivated by safety concerns but points nevertheless to an increased risk of diabetic ketoacidosis (DKA) associated with SGLT2 inhibitors in those with type 1 diabetes, which it said might cause “confusion” among physicians using the drug to treat numerous other indications for which this agent is now approved.
DKA is a potentially dangerous side effect resulting from acid build-up in the blood and is normally accompanied by very high glucose levels. DKA is flagged as a potential side effect in type 2 diabetes but is more common in those with type 1 diabetes. It can also occur as “euglycemic” DKA, which is ketosis but with relatively normal glucose levels (and therefore harder for patients to detect). Euglycemic DKA is thought to be more of a risk in those with type 1 diabetes than in those with type 2 diabetes.
One charity believes concerns around safety are the underlying factor for the withdrawal of dapagliflozin for type 1 diabetes in Europe, suggesting that AstraZeneca might not want to risk income from more lucrative indications – such as type 2 diabetes with much larger patient populations – because of potential concerns from doctors, who may be deterred from prescribing the drug due to concerns about DKA.
JDRF International, a leading global type 1 diabetes charity, called on AstraZeneca in a statement “to explain to people affected by type 1 diabetes why the drug has been withdrawn.”
It added that dapagliflozin is the “only other drug besides insulin” to be licensed in Europe for the treatment of type 1 diabetes and represents a “major advancement since the discovery of insulin 100 years ago.”
Karen Addington, U.K. Chief Executive of JDRF, said it is “appalling” that the drug has been withdrawn, as “many people with type 1 are finding it an effective and useful tool to help manage their glucose levels.”
SGLT2 inhibitors never approved for type 1 diabetes in U.S.
Dapagliflozin and other drugs from the SGLT2 inhibitor class had already been approved for the treatment of type 2 diabetes for a number of years when dapagliflozin was approved in early 2019 for the treatment of adults with type 1 diabetes meeting certain criteria by the European Medicines Agency (EMA), which at that time included the U.K. in its remit, based on data from the DEPICT series of phase 3 trials.
SGLT2 inhibitors have also recently shown benefit in other indications, such as heart failure and chronic kidney disease – even in the absence of diabetes – leaving some to label them a new class of wonder drugs.
Following the 2019 EU approval for type 1 diabetes, dapagliflozin was subsequently recommended for this use on the National Health Service (NHS) in England and Wales and was accompanied by guidance from the National Institute for Health and Care Excellence (NICE), which has now had to be withdrawn.
Of note, dapagliflozin was never approved for use in type 1 diabetes in the United States (where it is known as Farxiga), with the U.S. Food and Drug Administration turning it down in July 2019.
An advisory panel for the FDA also later turned down another SGLT2 inhibitor for type 1 diabetes, empagliflozin (Jardiance, Boehringer Ingelheim) in Nov. 2019, as reported by this news organization.
Discontinuation ‘not due to safety concerns,’ says AZ
The announcement to discontinue dapagliflozin for the indication of type 1 diabetes in certain adults just two and a half years after its approval in the EU comes as a big surprise, especially as it was made with little fanfare just last month.
In the U.K., AstraZeneca sent a letter to health care professionals on Nov. 2 stating that, from Oct. 25, dapagliflozin 5 mg was “no longer authorized” for the treatment of type 1 diabetes and “should no longer be used” in this patient population.
However, it underlined that other indications for dapagliflozin 5 mg and 10 mg were “not affected by this licensing change,” and it remains available for adults with type 2 diabetes, as well as for the management of symptomatic chronic heart feature with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD).
In the letter, sent by Tom Keith-Roach, country president of AstraZeneca UK, the company asserts that the removal of the type 1 diabetes indication from dapagliflozin is “not due to any safety concern” with the drug “in any indication, including type 1 diabetes.”
It nevertheless goes on to highlight that DKA is a known common side effect of dapagliflozin in type 1 diabetes and, following the announcement, “additional risk minimization measures ... will no longer be available.”
In a separate statement, AstraZeneca said that the decision to remove the indication was made “voluntarily” and had been “agreed” with the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the equivalent body in Northern Ireland.
“It follows discussions regarding product information changes needed post-approval for dapagliflozin 5 mg specific to type 1 diabetes,” the company said, “which might cause confusion” among physicians treating patients with type 2 diabetes, chronic heart feature with reduced ejection fraction, or CKD.
AstraZeneca told this news organization that similar communications about the withdrawal were issued to health care agencies and health care professionals in all countries of the EU.
‘Appalling, devastating, disappointing’ for patients
The announcement has been met with disappointment in some quarters and outrage in others, and questions have been raised as to the explanation given by AstraZeneca for the drug’s withdrawal.
“Although only a small number of people with type 1 diabetes have been using dapagliflozin, we know that those who have been using it will have been benefitting from tighter control of their condition,” Simon O’Neill, director of health intelligence and professional liaison at Diabetes UK, told this news organization.
“It’s disappointing that these people will now need to go back to the drawing board and will have to work with their clinical team to find other ways of better managing their condition.”
Mr. O’Neill said it was “disappointing that AstraZeneca and the MHRA were unable to find a workable solution to allow people living with type 1 diabetes to continue using the drug safely without leading to confusion for clinicians or people living with type 2 diabetes, who also use it.”
Sanjoy Dutta, JDRF International vice president of research, added that the news is “devastating.”
“The impending negative impact of removing a drug like dapagliflozin from any market can be detrimental in the potential for other national medical ruling boards to have confidence in approving it for their citizens,” he added.
“We stand with our type 1 diabetes communities across the globe in demanding an explanation to clarify this removal.”
Why not an educational campaign about DKA risk?
In an interview, Hilary Nathan, policy & communications director at JDRF International, explained that the charity has its theories as to why dapagliflozin has been withdrawn for type 1 diabetes.
What AstraZeneca is saying, “and what we don’t agree with them on,” is that the “black triangle” warning that has to be put onto the drug due to the increased risk of DKA in type 1 diabetes is “misunderstood by health care practitioners” outside of that specialty and that “by having that black triangle, it will inhibit take-up in those other markets.”
In other words, “there will be less desire to prescribe it,” ventured Ms. Nathan.
She continued: “For us, we feel that if a medicine is deemed safe and efficacious, it should not be withdrawn because of other patient constituencies.”
“We asked: ‘Why can’t you do an educational awareness campaign about the black triangle?’ And the might of AstraZeneca said it would be too big a task.”
Ms. Nathan was also surprised at how the drug could be withdrawn without any warning or real explanation.
“How is it possible that, when a drug is approved there are multiple stakeholders that are involved in putting forward views and experiences – both from the clinical and patient advocacy communities, as well as obviously the pharmaceutical community – yet [a drug] can be withdrawn by a ... company that may well have conflicts of interest around commercial take-up.”
She added: “I feel that there are potentially motives around the withdrawal that AstraZeneca are still not being clear about.”
Perhaps a further clue as to the real motives behind the withdrawal can be found in an announcement, just last week, by the British MHRA.
“The decision by the marketing authorization holder to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorization,” it said.
“The decision was not driven by any new safety concerns, such as the already known increased risk of DKA in type 1 diabetes compared with type 2 diabetes.”
Separately, a new in-depth investigation into when Johnson & Johnson, which markets another SGLT2 inhibitor, canagliflozin (Invokana), first knew that its agent was associated with DKA has revealed multiple discrepancies in staff accounts. Some claim the company knew as early as 2010 that canagliflozin – first approved for type 2 diabetes in the United States in 2013 – could increase the risk of DKA. It was not until May 2015 that the FDA first issued a warning about the potential risk of DKA associated with use of SGLT2 inhibitors, with the EMA following suit a month later. In Dec. 2015, the FDA updated the labels for all SGLT2 inhibitors approved in the United States at that time – canagliflozin, empagliflozin, and dapagliflozin – to include the risks for ketoacidosis (and urinary tract infections).
Forxiga (dapagliflozin) is manufactured by AstraZeneca. No relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
In a shocking, yet low-key, announcement, the sodium-glucose transporter 2 (SGLT2) inhibitor dapagliflozin (Forxiga, AstraZeneca) has been withdrawn from the market in all EU countries for the indication of type 1 diabetes.
This includes withdrawal in the U.K., which was part of the EU when dapagliflozin was approved for type 1 diabetes in 2019, but following Brexit, is no longer.
AstraZeneca said the decision is not motivated by safety concerns but points nevertheless to an increased risk of diabetic ketoacidosis (DKA) associated with SGLT2 inhibitors in those with type 1 diabetes, which it said might cause “confusion” among physicians using the drug to treat numerous other indications for which this agent is now approved.
DKA is a potentially dangerous side effect resulting from acid build-up in the blood and is normally accompanied by very high glucose levels. DKA is flagged as a potential side effect in type 2 diabetes but is more common in those with type 1 diabetes. It can also occur as “euglycemic” DKA, which is ketosis but with relatively normal glucose levels (and therefore harder for patients to detect). Euglycemic DKA is thought to be more of a risk in those with type 1 diabetes than in those with type 2 diabetes.
One charity believes concerns around safety are the underlying factor for the withdrawal of dapagliflozin for type 1 diabetes in Europe, suggesting that AstraZeneca might not want to risk income from more lucrative indications – such as type 2 diabetes with much larger patient populations – because of potential concerns from doctors, who may be deterred from prescribing the drug due to concerns about DKA.
JDRF International, a leading global type 1 diabetes charity, called on AstraZeneca in a statement “to explain to people affected by type 1 diabetes why the drug has been withdrawn.”
It added that dapagliflozin is the “only other drug besides insulin” to be licensed in Europe for the treatment of type 1 diabetes and represents a “major advancement since the discovery of insulin 100 years ago.”
Karen Addington, U.K. Chief Executive of JDRF, said it is “appalling” that the drug has been withdrawn, as “many people with type 1 are finding it an effective and useful tool to help manage their glucose levels.”
SGLT2 inhibitors never approved for type 1 diabetes in U.S.
Dapagliflozin and other drugs from the SGLT2 inhibitor class had already been approved for the treatment of type 2 diabetes for a number of years when dapagliflozin was approved in early 2019 for the treatment of adults with type 1 diabetes meeting certain criteria by the European Medicines Agency (EMA), which at that time included the U.K. in its remit, based on data from the DEPICT series of phase 3 trials.
SGLT2 inhibitors have also recently shown benefit in other indications, such as heart failure and chronic kidney disease – even in the absence of diabetes – leaving some to label them a new class of wonder drugs.
Following the 2019 EU approval for type 1 diabetes, dapagliflozin was subsequently recommended for this use on the National Health Service (NHS) in England and Wales and was accompanied by guidance from the National Institute for Health and Care Excellence (NICE), which has now had to be withdrawn.
Of note, dapagliflozin was never approved for use in type 1 diabetes in the United States (where it is known as Farxiga), with the U.S. Food and Drug Administration turning it down in July 2019.
An advisory panel for the FDA also later turned down another SGLT2 inhibitor for type 1 diabetes, empagliflozin (Jardiance, Boehringer Ingelheim) in Nov. 2019, as reported by this news organization.
Discontinuation ‘not due to safety concerns,’ says AZ
The announcement to discontinue dapagliflozin for the indication of type 1 diabetes in certain adults just two and a half years after its approval in the EU comes as a big surprise, especially as it was made with little fanfare just last month.
In the U.K., AstraZeneca sent a letter to health care professionals on Nov. 2 stating that, from Oct. 25, dapagliflozin 5 mg was “no longer authorized” for the treatment of type 1 diabetes and “should no longer be used” in this patient population.
However, it underlined that other indications for dapagliflozin 5 mg and 10 mg were “not affected by this licensing change,” and it remains available for adults with type 2 diabetes, as well as for the management of symptomatic chronic heart feature with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD).
In the letter, sent by Tom Keith-Roach, country president of AstraZeneca UK, the company asserts that the removal of the type 1 diabetes indication from dapagliflozin is “not due to any safety concern” with the drug “in any indication, including type 1 diabetes.”
It nevertheless goes on to highlight that DKA is a known common side effect of dapagliflozin in type 1 diabetes and, following the announcement, “additional risk minimization measures ... will no longer be available.”
In a separate statement, AstraZeneca said that the decision to remove the indication was made “voluntarily” and had been “agreed” with the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the equivalent body in Northern Ireland.
“It follows discussions regarding product information changes needed post-approval for dapagliflozin 5 mg specific to type 1 diabetes,” the company said, “which might cause confusion” among physicians treating patients with type 2 diabetes, chronic heart feature with reduced ejection fraction, or CKD.
AstraZeneca told this news organization that similar communications about the withdrawal were issued to health care agencies and health care professionals in all countries of the EU.
‘Appalling, devastating, disappointing’ for patients
The announcement has been met with disappointment in some quarters and outrage in others, and questions have been raised as to the explanation given by AstraZeneca for the drug’s withdrawal.
“Although only a small number of people with type 1 diabetes have been using dapagliflozin, we know that those who have been using it will have been benefitting from tighter control of their condition,” Simon O’Neill, director of health intelligence and professional liaison at Diabetes UK, told this news organization.
“It’s disappointing that these people will now need to go back to the drawing board and will have to work with their clinical team to find other ways of better managing their condition.”
Mr. O’Neill said it was “disappointing that AstraZeneca and the MHRA were unable to find a workable solution to allow people living with type 1 diabetes to continue using the drug safely without leading to confusion for clinicians or people living with type 2 diabetes, who also use it.”
Sanjoy Dutta, JDRF International vice president of research, added that the news is “devastating.”
“The impending negative impact of removing a drug like dapagliflozin from any market can be detrimental in the potential for other national medical ruling boards to have confidence in approving it for their citizens,” he added.
“We stand with our type 1 diabetes communities across the globe in demanding an explanation to clarify this removal.”
Why not an educational campaign about DKA risk?
In an interview, Hilary Nathan, policy & communications director at JDRF International, explained that the charity has its theories as to why dapagliflozin has been withdrawn for type 1 diabetes.
What AstraZeneca is saying, “and what we don’t agree with them on,” is that the “black triangle” warning that has to be put onto the drug due to the increased risk of DKA in type 1 diabetes is “misunderstood by health care practitioners” outside of that specialty and that “by having that black triangle, it will inhibit take-up in those other markets.”
In other words, “there will be less desire to prescribe it,” ventured Ms. Nathan.
She continued: “For us, we feel that if a medicine is deemed safe and efficacious, it should not be withdrawn because of other patient constituencies.”
“We asked: ‘Why can’t you do an educational awareness campaign about the black triangle?’ And the might of AstraZeneca said it would be too big a task.”
Ms. Nathan was also surprised at how the drug could be withdrawn without any warning or real explanation.
“How is it possible that, when a drug is approved there are multiple stakeholders that are involved in putting forward views and experiences – both from the clinical and patient advocacy communities, as well as obviously the pharmaceutical community – yet [a drug] can be withdrawn by a ... company that may well have conflicts of interest around commercial take-up.”
She added: “I feel that there are potentially motives around the withdrawal that AstraZeneca are still not being clear about.”
Perhaps a further clue as to the real motives behind the withdrawal can be found in an announcement, just last week, by the British MHRA.
“The decision by the marketing authorization holder to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorization,” it said.
“The decision was not driven by any new safety concerns, such as the already known increased risk of DKA in type 1 diabetes compared with type 2 diabetes.”
Separately, a new in-depth investigation into when Johnson & Johnson, which markets another SGLT2 inhibitor, canagliflozin (Invokana), first knew that its agent was associated with DKA has revealed multiple discrepancies in staff accounts. Some claim the company knew as early as 2010 that canagliflozin – first approved for type 2 diabetes in the United States in 2013 – could increase the risk of DKA. It was not until May 2015 that the FDA first issued a warning about the potential risk of DKA associated with use of SGLT2 inhibitors, with the EMA following suit a month later. In Dec. 2015, the FDA updated the labels for all SGLT2 inhibitors approved in the United States at that time – canagliflozin, empagliflozin, and dapagliflozin – to include the risks for ketoacidosis (and urinary tract infections).
Forxiga (dapagliflozin) is manufactured by AstraZeneca. No relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
In a shocking, yet low-key, announcement, the sodium-glucose transporter 2 (SGLT2) inhibitor dapagliflozin (Forxiga, AstraZeneca) has been withdrawn from the market in all EU countries for the indication of type 1 diabetes.
This includes withdrawal in the U.K., which was part of the EU when dapagliflozin was approved for type 1 diabetes in 2019, but following Brexit, is no longer.
AstraZeneca said the decision is not motivated by safety concerns but points nevertheless to an increased risk of diabetic ketoacidosis (DKA) associated with SGLT2 inhibitors in those with type 1 diabetes, which it said might cause “confusion” among physicians using the drug to treat numerous other indications for which this agent is now approved.
DKA is a potentially dangerous side effect resulting from acid build-up in the blood and is normally accompanied by very high glucose levels. DKA is flagged as a potential side effect in type 2 diabetes but is more common in those with type 1 diabetes. It can also occur as “euglycemic” DKA, which is ketosis but with relatively normal glucose levels (and therefore harder for patients to detect). Euglycemic DKA is thought to be more of a risk in those with type 1 diabetes than in those with type 2 diabetes.
One charity believes concerns around safety are the underlying factor for the withdrawal of dapagliflozin for type 1 diabetes in Europe, suggesting that AstraZeneca might not want to risk income from more lucrative indications – such as type 2 diabetes with much larger patient populations – because of potential concerns from doctors, who may be deterred from prescribing the drug due to concerns about DKA.
JDRF International, a leading global type 1 diabetes charity, called on AstraZeneca in a statement “to explain to people affected by type 1 diabetes why the drug has been withdrawn.”
It added that dapagliflozin is the “only other drug besides insulin” to be licensed in Europe for the treatment of type 1 diabetes and represents a “major advancement since the discovery of insulin 100 years ago.”
Karen Addington, U.K. Chief Executive of JDRF, said it is “appalling” that the drug has been withdrawn, as “many people with type 1 are finding it an effective and useful tool to help manage their glucose levels.”
SGLT2 inhibitors never approved for type 1 diabetes in U.S.
Dapagliflozin and other drugs from the SGLT2 inhibitor class had already been approved for the treatment of type 2 diabetes for a number of years when dapagliflozin was approved in early 2019 for the treatment of adults with type 1 diabetes meeting certain criteria by the European Medicines Agency (EMA), which at that time included the U.K. in its remit, based on data from the DEPICT series of phase 3 trials.
SGLT2 inhibitors have also recently shown benefit in other indications, such as heart failure and chronic kidney disease – even in the absence of diabetes – leaving some to label them a new class of wonder drugs.
Following the 2019 EU approval for type 1 diabetes, dapagliflozin was subsequently recommended for this use on the National Health Service (NHS) in England and Wales and was accompanied by guidance from the National Institute for Health and Care Excellence (NICE), which has now had to be withdrawn.
Of note, dapagliflozin was never approved for use in type 1 diabetes in the United States (where it is known as Farxiga), with the U.S. Food and Drug Administration turning it down in July 2019.
An advisory panel for the FDA also later turned down another SGLT2 inhibitor for type 1 diabetes, empagliflozin (Jardiance, Boehringer Ingelheim) in Nov. 2019, as reported by this news organization.
Discontinuation ‘not due to safety concerns,’ says AZ
The announcement to discontinue dapagliflozin for the indication of type 1 diabetes in certain adults just two and a half years after its approval in the EU comes as a big surprise, especially as it was made with little fanfare just last month.
In the U.K., AstraZeneca sent a letter to health care professionals on Nov. 2 stating that, from Oct. 25, dapagliflozin 5 mg was “no longer authorized” for the treatment of type 1 diabetes and “should no longer be used” in this patient population.
However, it underlined that other indications for dapagliflozin 5 mg and 10 mg were “not affected by this licensing change,” and it remains available for adults with type 2 diabetes, as well as for the management of symptomatic chronic heart feature with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD).
In the letter, sent by Tom Keith-Roach, country president of AstraZeneca UK, the company asserts that the removal of the type 1 diabetes indication from dapagliflozin is “not due to any safety concern” with the drug “in any indication, including type 1 diabetes.”
It nevertheless goes on to highlight that DKA is a known common side effect of dapagliflozin in type 1 diabetes and, following the announcement, “additional risk minimization measures ... will no longer be available.”
In a separate statement, AstraZeneca said that the decision to remove the indication was made “voluntarily” and had been “agreed” with the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the equivalent body in Northern Ireland.
“It follows discussions regarding product information changes needed post-approval for dapagliflozin 5 mg specific to type 1 diabetes,” the company said, “which might cause confusion” among physicians treating patients with type 2 diabetes, chronic heart feature with reduced ejection fraction, or CKD.
AstraZeneca told this news organization that similar communications about the withdrawal were issued to health care agencies and health care professionals in all countries of the EU.
‘Appalling, devastating, disappointing’ for patients
The announcement has been met with disappointment in some quarters and outrage in others, and questions have been raised as to the explanation given by AstraZeneca for the drug’s withdrawal.
“Although only a small number of people with type 1 diabetes have been using dapagliflozin, we know that those who have been using it will have been benefitting from tighter control of their condition,” Simon O’Neill, director of health intelligence and professional liaison at Diabetes UK, told this news organization.
“It’s disappointing that these people will now need to go back to the drawing board and will have to work with their clinical team to find other ways of better managing their condition.”
Mr. O’Neill said it was “disappointing that AstraZeneca and the MHRA were unable to find a workable solution to allow people living with type 1 diabetes to continue using the drug safely without leading to confusion for clinicians or people living with type 2 diabetes, who also use it.”
Sanjoy Dutta, JDRF International vice president of research, added that the news is “devastating.”
“The impending negative impact of removing a drug like dapagliflozin from any market can be detrimental in the potential for other national medical ruling boards to have confidence in approving it for their citizens,” he added.
“We stand with our type 1 diabetes communities across the globe in demanding an explanation to clarify this removal.”
Why not an educational campaign about DKA risk?
In an interview, Hilary Nathan, policy & communications director at JDRF International, explained that the charity has its theories as to why dapagliflozin has been withdrawn for type 1 diabetes.
What AstraZeneca is saying, “and what we don’t agree with them on,” is that the “black triangle” warning that has to be put onto the drug due to the increased risk of DKA in type 1 diabetes is “misunderstood by health care practitioners” outside of that specialty and that “by having that black triangle, it will inhibit take-up in those other markets.”
In other words, “there will be less desire to prescribe it,” ventured Ms. Nathan.
She continued: “For us, we feel that if a medicine is deemed safe and efficacious, it should not be withdrawn because of other patient constituencies.”
“We asked: ‘Why can’t you do an educational awareness campaign about the black triangle?’ And the might of AstraZeneca said it would be too big a task.”
Ms. Nathan was also surprised at how the drug could be withdrawn without any warning or real explanation.
“How is it possible that, when a drug is approved there are multiple stakeholders that are involved in putting forward views and experiences – both from the clinical and patient advocacy communities, as well as obviously the pharmaceutical community – yet [a drug] can be withdrawn by a ... company that may well have conflicts of interest around commercial take-up.”
She added: “I feel that there are potentially motives around the withdrawal that AstraZeneca are still not being clear about.”
Perhaps a further clue as to the real motives behind the withdrawal can be found in an announcement, just last week, by the British MHRA.
“The decision by the marketing authorization holder to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorization,” it said.
“The decision was not driven by any new safety concerns, such as the already known increased risk of DKA in type 1 diabetes compared with type 2 diabetes.”
Separately, a new in-depth investigation into when Johnson & Johnson, which markets another SGLT2 inhibitor, canagliflozin (Invokana), first knew that its agent was associated with DKA has revealed multiple discrepancies in staff accounts. Some claim the company knew as early as 2010 that canagliflozin – first approved for type 2 diabetes in the United States in 2013 – could increase the risk of DKA. It was not until May 2015 that the FDA first issued a warning about the potential risk of DKA associated with use of SGLT2 inhibitors, with the EMA following suit a month later. In Dec. 2015, the FDA updated the labels for all SGLT2 inhibitors approved in the United States at that time – canagliflozin, empagliflozin, and dapagliflozin – to include the risks for ketoacidosis (and urinary tract infections).
Forxiga (dapagliflozin) is manufactured by AstraZeneca. No relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
FDA updates risks, cautions for clotting-bleeding disorder on Janssen COVID-19 vaccine
Updated Janssen/Johnson & Johnson COVID-19 vaccine fact sheets for health care professionals and the general public now include a contraindication to its use in persons with a history of thrombosis with thrombocytopenia after receiving it “or any other adenovirus-vectored COVID-19 vaccine,” the U.S. Food and Drug Administration has announced.
Thrombosis with thrombocytopenia syndrome (TTS) – thrombocytopenia and increased bleeding risk along with documented thrombosis – after administration of the Janssen Ad26.COV2.S vaccine remains rare. But over all age groups, about one in seven cases have been fatal, said the agency.
the provider fact sheet states.
Although TTS associated with the Janssen COVID-19 vaccine has been reported in men and women aged 18 and older, the highest reported rate has been for women aged 30-49, the agency states. The rate in that group has been about 1 case per 100,000 doses administered.
Symptoms of TTS may occur 1-2 weeks after administration of the Janssen COVID-19 vaccine, the FDA says, based on data from the Vaccine Adverse Events Reporting System (VAERS).
Its clinical course shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS following receipt of the Janssen COVID-19 vaccine, the agency cautions, the use of heparin “may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”
The apparent excess risk of TTS remains under investigation, but “the FDA continues to find that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older,” the agency states.
A version of this article first appeared on Medscape.com.
Updated Janssen/Johnson & Johnson COVID-19 vaccine fact sheets for health care professionals and the general public now include a contraindication to its use in persons with a history of thrombosis with thrombocytopenia after receiving it “or any other adenovirus-vectored COVID-19 vaccine,” the U.S. Food and Drug Administration has announced.
Thrombosis with thrombocytopenia syndrome (TTS) – thrombocytopenia and increased bleeding risk along with documented thrombosis – after administration of the Janssen Ad26.COV2.S vaccine remains rare. But over all age groups, about one in seven cases have been fatal, said the agency.
the provider fact sheet states.
Although TTS associated with the Janssen COVID-19 vaccine has been reported in men and women aged 18 and older, the highest reported rate has been for women aged 30-49, the agency states. The rate in that group has been about 1 case per 100,000 doses administered.
Symptoms of TTS may occur 1-2 weeks after administration of the Janssen COVID-19 vaccine, the FDA says, based on data from the Vaccine Adverse Events Reporting System (VAERS).
Its clinical course shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS following receipt of the Janssen COVID-19 vaccine, the agency cautions, the use of heparin “may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”
The apparent excess risk of TTS remains under investigation, but “the FDA continues to find that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older,” the agency states.
A version of this article first appeared on Medscape.com.
Updated Janssen/Johnson & Johnson COVID-19 vaccine fact sheets for health care professionals and the general public now include a contraindication to its use in persons with a history of thrombosis with thrombocytopenia after receiving it “or any other adenovirus-vectored COVID-19 vaccine,” the U.S. Food and Drug Administration has announced.
Thrombosis with thrombocytopenia syndrome (TTS) – thrombocytopenia and increased bleeding risk along with documented thrombosis – after administration of the Janssen Ad26.COV2.S vaccine remains rare. But over all age groups, about one in seven cases have been fatal, said the agency.
the provider fact sheet states.
Although TTS associated with the Janssen COVID-19 vaccine has been reported in men and women aged 18 and older, the highest reported rate has been for women aged 30-49, the agency states. The rate in that group has been about 1 case per 100,000 doses administered.
Symptoms of TTS may occur 1-2 weeks after administration of the Janssen COVID-19 vaccine, the FDA says, based on data from the Vaccine Adverse Events Reporting System (VAERS).
Its clinical course shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS following receipt of the Janssen COVID-19 vaccine, the agency cautions, the use of heparin “may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”
The apparent excess risk of TTS remains under investigation, but “the FDA continues to find that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older,” the agency states.
A version of this article first appeared on Medscape.com.
Medicare insulin negotiations seen saving $17 billion
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
Even COVID-19 can’t stop a true optimist
Squeezing a little lemonade out of COVID-19
We like to think of ourselves as optimists here at LOTME. A glass is half full, the sky is partly sunny, and our motto is “Always look on the bright side of insanity.” Then again, our motto before that was “LOTME: Where science meets stupid,” so what do we know?
Anyway, it’s that upbeat, can-do attitude that allows us to say something positive – two somethings, actually – about the insanity that is COVID-19.
Our journey to the bright side begins, oddly enough, in the courtroom. Seems that our old friend, the face mask, is something of a lie-detector aid for juries. The authors of a recent literature review of studies on deception “found that facial expressions and other forms of nonverbal behaviour are an unreliable indicator of deceit,” according to a statement from the University of Portsmouth, where the analysis was conducted.
The one study that directly examined the role of face coverings in court proceedings showed that, “by taking away the distraction of nonverbal behaviours, observers had to rely on speech content, which turned out to be better for detecting lies,” the university said.
The second stage of our positivity trek brings us to the National Trends in Disability Employment monthly update, where we see a fourth consecutive month of gains for people with disabilities despite the larger trend of declines among those without disabilities.
Here are some numbers from the Kessler Foundation and the University of New Hampshire’s Institute on Disability to tell the story: From October to November, the employment-to-population ratio increased 4.2% for working-age people with disabilities, compared with 0.4% for people without disabilities. At the same time, the labor force participation rate rose 2.4% for working-age people with disabilities and just 0.1% for working-age people without disabilities.
Both indicators surpassed their historic highs, Andrew Houtenville, PhD, director of the Institute on Disability, said in the update. “These gains suggest that the restructuring resulting from the pandemic may be benefiting people with disabilities. Ironically, it may have taken a pandemic to shake the labor market loose for people with disabilities.”
And that is how a world-class optimist turns one gigantic lemon into lemonade.
Cut the cheese for better sleep
So, we’ve already talked about the TikTok lettuce tea hack that’s supposed to help us sleep better. Well, there’s another food that could have the opposite effect.
According to an article from the BBC, cheese has something of a reputation. Ever since the 1960s, when a researcher noted that one patient’s nightmares stopped after he quit eating an ounce or two of cheddar each night, there’s been speculation that cheese gives you weird dreams. Another study in 2005 suggested certain types of cheese cause certain types of dreams. Blue cheese for vivid dreams and cheddar cheese for celebrity cameos.
But is there any truth to it at all?
Regardless of what we eat, going to bed hungry could cause vivid dreams, according to research by Tore Nielsen, director of the University of Montreal’s dream and nightmare lab. The 2015 study showed that high lactose could have an effect on dreams.
In that study, 17% of participants said their dreams were influenced by what they ate, but the kicker was that dairy products were the foods most reported as causing the weird dreams, the BBC noted.
“It’s likely an indirect effect in that lactose produces symptoms like gas, bloating and diarrhoea and influences dreams, as dreams draw on somatic sources like this. And if you have certain kinds of intolerances, you still may be likely to eat those foods sometimes,” Mr. Nielsen told the BBC.
There’s also the theory that it’s all in the timing of consumption. Are you the type of person to sneak a slice of cheese from the fridge late at night? (Nods.) Same.
“One reason cheese and nightmares come about is that eating later before bed is more likely to disrupt sleep, and cheese can be hard to digest,” said Charlotte Gupta, a research fellow at Central Queensland University in Australia and a coauthor of a 2020 review on how diet affects our sleep.
So as tempting as it is, maybe skip sprinkling Parmesan cheese shreds into your mouth at the open fridge before bed.
Teeing up against Parkinson’s
For the nearly 1 million people in the United States with Parkinson’s disease, tai chi is one of the best ways to alleviate the symptoms. The average Parkinson’s patient, however, is going to be on the older side and more likely to view the martial art as some sort of communist plot. And would you participate in a communist plot? We don’t think so.
One group of researchers saw that patients weren’t keeping up with their therapy and decided to try a different activity, something that older people would be more likely to stick with. Something a bit more stereotypical. No, not shuffleboard. They tried golf.
“Golf is popular – the most popular sport for people over the age of 55 – which might encourage people to try it and stick with it,” study author Anne-Marie A. Wills, MD, of Massachusetts General Hospital, Boston, said in a Study Finds report.
In a small study, the investigators had a group of patients with Parkinson’s regularly go to a driving range for 10 weeks to hit golf balls (all expenses paid too, and that’s a big deal for golf), while another group continued with their tai chi.
At the end of the study, the 8 patients who went to the driving range had significantly better results in a Parkinson’s mobility test than those of the 12 patients in the tai chi group. In addition, the golf-group participants said they were more likely to continue with their therapy than were those who did tai chi.
Despite the small size of the study, the research team said the results certainly warrant further research. After all, the best sort of therapy is the kind that actually gets done. And golf just gets in your head. The eternal quest to add distance, to straighten out that annoying slice, to stop thinning half your chips, to make those annoying 4-footers. ... Maybe that’s just us.
Squeezing a little lemonade out of COVID-19
We like to think of ourselves as optimists here at LOTME. A glass is half full, the sky is partly sunny, and our motto is “Always look on the bright side of insanity.” Then again, our motto before that was “LOTME: Where science meets stupid,” so what do we know?
Anyway, it’s that upbeat, can-do attitude that allows us to say something positive – two somethings, actually – about the insanity that is COVID-19.
Our journey to the bright side begins, oddly enough, in the courtroom. Seems that our old friend, the face mask, is something of a lie-detector aid for juries. The authors of a recent literature review of studies on deception “found that facial expressions and other forms of nonverbal behaviour are an unreliable indicator of deceit,” according to a statement from the University of Portsmouth, where the analysis was conducted.
The one study that directly examined the role of face coverings in court proceedings showed that, “by taking away the distraction of nonverbal behaviours, observers had to rely on speech content, which turned out to be better for detecting lies,” the university said.
The second stage of our positivity trek brings us to the National Trends in Disability Employment monthly update, where we see a fourth consecutive month of gains for people with disabilities despite the larger trend of declines among those without disabilities.
Here are some numbers from the Kessler Foundation and the University of New Hampshire’s Institute on Disability to tell the story: From October to November, the employment-to-population ratio increased 4.2% for working-age people with disabilities, compared with 0.4% for people without disabilities. At the same time, the labor force participation rate rose 2.4% for working-age people with disabilities and just 0.1% for working-age people without disabilities.
Both indicators surpassed their historic highs, Andrew Houtenville, PhD, director of the Institute on Disability, said in the update. “These gains suggest that the restructuring resulting from the pandemic may be benefiting people with disabilities. Ironically, it may have taken a pandemic to shake the labor market loose for people with disabilities.”
And that is how a world-class optimist turns one gigantic lemon into lemonade.
Cut the cheese for better sleep
So, we’ve already talked about the TikTok lettuce tea hack that’s supposed to help us sleep better. Well, there’s another food that could have the opposite effect.
According to an article from the BBC, cheese has something of a reputation. Ever since the 1960s, when a researcher noted that one patient’s nightmares stopped after he quit eating an ounce or two of cheddar each night, there’s been speculation that cheese gives you weird dreams. Another study in 2005 suggested certain types of cheese cause certain types of dreams. Blue cheese for vivid dreams and cheddar cheese for celebrity cameos.
But is there any truth to it at all?
Regardless of what we eat, going to bed hungry could cause vivid dreams, according to research by Tore Nielsen, director of the University of Montreal’s dream and nightmare lab. The 2015 study showed that high lactose could have an effect on dreams.
In that study, 17% of participants said their dreams were influenced by what they ate, but the kicker was that dairy products were the foods most reported as causing the weird dreams, the BBC noted.
“It’s likely an indirect effect in that lactose produces symptoms like gas, bloating and diarrhoea and influences dreams, as dreams draw on somatic sources like this. And if you have certain kinds of intolerances, you still may be likely to eat those foods sometimes,” Mr. Nielsen told the BBC.
There’s also the theory that it’s all in the timing of consumption. Are you the type of person to sneak a slice of cheese from the fridge late at night? (Nods.) Same.
“One reason cheese and nightmares come about is that eating later before bed is more likely to disrupt sleep, and cheese can be hard to digest,” said Charlotte Gupta, a research fellow at Central Queensland University in Australia and a coauthor of a 2020 review on how diet affects our sleep.
So as tempting as it is, maybe skip sprinkling Parmesan cheese shreds into your mouth at the open fridge before bed.
Teeing up against Parkinson’s
For the nearly 1 million people in the United States with Parkinson’s disease, tai chi is one of the best ways to alleviate the symptoms. The average Parkinson’s patient, however, is going to be on the older side and more likely to view the martial art as some sort of communist plot. And would you participate in a communist plot? We don’t think so.
One group of researchers saw that patients weren’t keeping up with their therapy and decided to try a different activity, something that older people would be more likely to stick with. Something a bit more stereotypical. No, not shuffleboard. They tried golf.
“Golf is popular – the most popular sport for people over the age of 55 – which might encourage people to try it and stick with it,” study author Anne-Marie A. Wills, MD, of Massachusetts General Hospital, Boston, said in a Study Finds report.
In a small study, the investigators had a group of patients with Parkinson’s regularly go to a driving range for 10 weeks to hit golf balls (all expenses paid too, and that’s a big deal for golf), while another group continued with their tai chi.
At the end of the study, the 8 patients who went to the driving range had significantly better results in a Parkinson’s mobility test than those of the 12 patients in the tai chi group. In addition, the golf-group participants said they were more likely to continue with their therapy than were those who did tai chi.
Despite the small size of the study, the research team said the results certainly warrant further research. After all, the best sort of therapy is the kind that actually gets done. And golf just gets in your head. The eternal quest to add distance, to straighten out that annoying slice, to stop thinning half your chips, to make those annoying 4-footers. ... Maybe that’s just us.
Squeezing a little lemonade out of COVID-19
We like to think of ourselves as optimists here at LOTME. A glass is half full, the sky is partly sunny, and our motto is “Always look on the bright side of insanity.” Then again, our motto before that was “LOTME: Where science meets stupid,” so what do we know?
Anyway, it’s that upbeat, can-do attitude that allows us to say something positive – two somethings, actually – about the insanity that is COVID-19.
Our journey to the bright side begins, oddly enough, in the courtroom. Seems that our old friend, the face mask, is something of a lie-detector aid for juries. The authors of a recent literature review of studies on deception “found that facial expressions and other forms of nonverbal behaviour are an unreliable indicator of deceit,” according to a statement from the University of Portsmouth, where the analysis was conducted.
The one study that directly examined the role of face coverings in court proceedings showed that, “by taking away the distraction of nonverbal behaviours, observers had to rely on speech content, which turned out to be better for detecting lies,” the university said.
The second stage of our positivity trek brings us to the National Trends in Disability Employment monthly update, where we see a fourth consecutive month of gains for people with disabilities despite the larger trend of declines among those without disabilities.
Here are some numbers from the Kessler Foundation and the University of New Hampshire’s Institute on Disability to tell the story: From October to November, the employment-to-population ratio increased 4.2% for working-age people with disabilities, compared with 0.4% for people without disabilities. At the same time, the labor force participation rate rose 2.4% for working-age people with disabilities and just 0.1% for working-age people without disabilities.
Both indicators surpassed their historic highs, Andrew Houtenville, PhD, director of the Institute on Disability, said in the update. “These gains suggest that the restructuring resulting from the pandemic may be benefiting people with disabilities. Ironically, it may have taken a pandemic to shake the labor market loose for people with disabilities.”
And that is how a world-class optimist turns one gigantic lemon into lemonade.
Cut the cheese for better sleep
So, we’ve already talked about the TikTok lettuce tea hack that’s supposed to help us sleep better. Well, there’s another food that could have the opposite effect.
According to an article from the BBC, cheese has something of a reputation. Ever since the 1960s, when a researcher noted that one patient’s nightmares stopped after he quit eating an ounce or two of cheddar each night, there’s been speculation that cheese gives you weird dreams. Another study in 2005 suggested certain types of cheese cause certain types of dreams. Blue cheese for vivid dreams and cheddar cheese for celebrity cameos.
But is there any truth to it at all?
Regardless of what we eat, going to bed hungry could cause vivid dreams, according to research by Tore Nielsen, director of the University of Montreal’s dream and nightmare lab. The 2015 study showed that high lactose could have an effect on dreams.
In that study, 17% of participants said their dreams were influenced by what they ate, but the kicker was that dairy products were the foods most reported as causing the weird dreams, the BBC noted.
“It’s likely an indirect effect in that lactose produces symptoms like gas, bloating and diarrhoea and influences dreams, as dreams draw on somatic sources like this. And if you have certain kinds of intolerances, you still may be likely to eat those foods sometimes,” Mr. Nielsen told the BBC.
There’s also the theory that it’s all in the timing of consumption. Are you the type of person to sneak a slice of cheese from the fridge late at night? (Nods.) Same.
“One reason cheese and nightmares come about is that eating later before bed is more likely to disrupt sleep, and cheese can be hard to digest,” said Charlotte Gupta, a research fellow at Central Queensland University in Australia and a coauthor of a 2020 review on how diet affects our sleep.
So as tempting as it is, maybe skip sprinkling Parmesan cheese shreds into your mouth at the open fridge before bed.
Teeing up against Parkinson’s
For the nearly 1 million people in the United States with Parkinson’s disease, tai chi is one of the best ways to alleviate the symptoms. The average Parkinson’s patient, however, is going to be on the older side and more likely to view the martial art as some sort of communist plot. And would you participate in a communist plot? We don’t think so.
One group of researchers saw that patients weren’t keeping up with their therapy and decided to try a different activity, something that older people would be more likely to stick with. Something a bit more stereotypical. No, not shuffleboard. They tried golf.
“Golf is popular – the most popular sport for people over the age of 55 – which might encourage people to try it and stick with it,” study author Anne-Marie A. Wills, MD, of Massachusetts General Hospital, Boston, said in a Study Finds report.
In a small study, the investigators had a group of patients with Parkinson’s regularly go to a driving range for 10 weeks to hit golf balls (all expenses paid too, and that’s a big deal for golf), while another group continued with their tai chi.
At the end of the study, the 8 patients who went to the driving range had significantly better results in a Parkinson’s mobility test than those of the 12 patients in the tai chi group. In addition, the golf-group participants said they were more likely to continue with their therapy than were those who did tai chi.
Despite the small size of the study, the research team said the results certainly warrant further research. After all, the best sort of therapy is the kind that actually gets done. And golf just gets in your head. The eternal quest to add distance, to straighten out that annoying slice, to stop thinning half your chips, to make those annoying 4-footers. ... Maybe that’s just us.
Discharge within 24 hours of PCI can be safe in select STEMI
Highly selected low-risk patients can be safely sent home about 24 hours after successful percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) when supported by intense, multidisciplinary virtual follow-up, a prospective study suggests for the first time.
The risk for major adverse cardiac events (MACE) in STEMI patients following an early hospital discharge (EHD) pathway was similar at 9 months to that seen for propensity-matched historic control subjects who met the same EHD criteria but were discharged later than 48 hours.
The stay in almost half (48%) the early discharge group was 24 hours or less, according to the study, published Dec. 13 in the Journal of the American College of Cardiology.
“We’ve shown that if we use appropriate risk criteria and instigate the appropriate, safe follow-up that it’s safe to select and discharge low-risk patients at an earlier time period, such as 24 hours,” senior author Daniel A. Jones, PhD, Barts Heart Centre, London, this news organization.
“Obviously, it’s one center in one city in the world,” he said. “Whether it’s applicable at other heart site centers, I believe it is, but I think we need more data to be able to change guidelines.”
Current European Society of Cardiology guidelines say that select patients should be considered for early discharge 48 to 72 hours after STEMI, but the COVID-19 pandemic incentivized the team to try and push that window.
“The COVID pandemic essentially brought a focus on resources, on minimizing the risk to our patient population in terms of catching COVID within hospital,” he said. “It became clear that to maintain the heart site service, we probably needed to get people out a bit quicker than we did before, so we came up with this pathway.”
Between March 2020 and June 2021, 600 patients presenting with STEMI were entered into the EHD pathway if they met the following pre-existing criteria for 48- to 72-hour discharge:
- Left ventricular ejection fraction 40% or greater
- Successful primary PCI with TIMI flow grade 3
- Absence of bystander disease requiring inpatient revascularization
- No recurrent ischemic symptoms
- No heart failure
- No significant arrhythmias
- No hemodynamic instability
- No significant comorbidity
- Suitable social circumstances for early discharge
The patients were given cardiac rehabilitation counseling over the phone within 48 hours and blood pressure machines if not available at home. At weeks 2 and 8, they spoke virtually with a dedicated cardiology advanced care practitioner who up-titrated medications and answered any questions. At week 12, they were seen by an interventional cardiologist or at a high-risk prevention clinic.
Their mean age was 59.2 years, 86% were male, the median symptom-to-balloon time was 80 minutes, and median door-to-balloon time was 50 minutes.
The early discharge patients were compared with 700 historic control subjects who met the EHD criteria and were discharged after 48 hours from Oct. 2018 to June 2021 and 560 patients discharged on standard-care pathways between April 2020 and June 2021.
Those discharged after 48 hours were more likely to have an anterior MI, multivessel disease, and multivessel PCI.
Comparable outcomes
The median length of stay was 24.6 hours (minimum 17 hours, maximum 40 hours) for the EHD group, 56.1 hours for historic control subjects, and 78.9 hours for the standard-care group.
The introduction of the EHD pathway significantly reduced the overall length of stay for all STEMI patients compared with the pre-pathway period of Oct. 2018 to March 2020 (median, 3 vs. 2 days; P < .0001).
Length of stay varied among patients; however, 420 patients stayed 1 less night in the hospital with the remaining patients staying about 8 to 12 fewer hours, resulting in approximate savings of £450,000, the authors note.
Over a median follow-up of 271 days, there were no cardiovascular deaths, two deaths from COVID-19, and a MACE rate of 1.2% (two deaths, three unscheduled revascularizations, and two further MI presentations) in the EHD group. That compares with a 0.7% mortality and 1.9% rate of MACE among historic control subjects, neither of which were significantly different.
There was also no difference in mortality (0.34% vs. 0.69%; P = .410) or MACE (1.2% vs. 1.9%; P = .342) among 560 pairs of propensity-matched EHD patients and historic control subjects.
Mortality was 4.1% in the standard-care group; cardiovascular mortality was 2.2%, and the rate of MACE was 8.6%.
When patients were surveyed, 85% were “satisfied” or “very satisfied” with the EHD pathway, whereas 73% of control and standard-care patients were satisfied with their care. Three-fourths of EHD patients also reported saving money and 62.5% saved time off work because of the virtual follow-up.
Judgment calls
“They didn’t really tell us much about the patients who didn’t qualify into this ultra–low-risk group but, obviously, it’s highly selected,” Cindy Grines, MD, Northside Hospital Cardiovascular Institute, Lawrenceville, Georgia, said in an interview. “In the U.S., you don’t get those chest pain onset-to-reperfusion in 80 minutes. So that was really kind of shocking.”
It also suggests that early discharge was applied to patients who may have had minimal myocardial damage from the STEMI, she suggested. “Even in their own hospital system, a lot of patients who met the criteria on paper were kept longer than 48 hours. So a lot of it’s a judgment call.”
Additional red flags where physicians may overrule the early discharge protocol are very late perfusion, advanced age, severe renal insufficiency, profound anemia, cardiac arrest requiring more than brief resuscitation, bleeding complications, or symptomatic coronavirus, Dr. Grines and J. Jeffrey Marshall, MD, also from Northside, observe in an accompanying editorial.
About 60% of patients were suitable for the EHD pathway, Dr. Jones said. “Typically, they are quite low risk, but we still had four in 10 anterior infarct, and about 25% had left ventricular function between 40% and 45%. So even though the majority are low risk, there are patients in there that you would consider to have had a decent infarct.”
“I think this is applicable to patients at most centers, and probably anywhere between a third to a fifth of all patients presenting to heart centers would be suitable for this discharge pathway,” he said.
Dr. Grines said the pathway is “definitely feasible” but there aren’t enough patients studied to know with 100% certainty whether it’s safe. A single observational study also isn’t enough to change guidelines, which in the United States do not comment on length of stay.
“In the ultra-low-risk patients – such as the ones where you got them in very early and you almost aborted the infarct or if it was a very small infarct – you can kind of treat them like an unstable angina patient, where you can do the PCI and potentially discharge them in 24 hours,” Dr. Grines said. “I think most of us might agree on that.”
“The other thing you have to weigh is the risk/benefit ratio,” she said. “If you have no beds available, you end up rationing care to some extent. So if you have a patient that’s otherwise doing well after a very small MI and have an emergency room full of people that need to be admitted and they’re sicker, then you end up making those judgment calls.”
Dr. Jones pointed out that current guidelines are based largely on observational data and that the team is planning to pilot the EHD pathway at five to 10 centers around the United Kingdom or potentially in Europe or the United States.
“This is an area where a [randomized controlled trial] RCT would be expensive, whereas a well-coordinated multicenter registry would probably provide enough information to change guidelines,” he said. “We’re not suggesting that every STEMI patient is suitable, but people that are low risk that you would already be considering for early discharge I think can go a bit quicker.”
Dr. Jones has received funding from the Barts Charity and financial support for blood pressure machines from the Barts Guild. First author Krishnaraj Rathod has received funding from the National Institute for Health and Research in the form of an Academic Clinical Lectureship. All other authors, Dr. Grines, and Dr. Marshall report having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Highly selected low-risk patients can be safely sent home about 24 hours after successful percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) when supported by intense, multidisciplinary virtual follow-up, a prospective study suggests for the first time.
The risk for major adverse cardiac events (MACE) in STEMI patients following an early hospital discharge (EHD) pathway was similar at 9 months to that seen for propensity-matched historic control subjects who met the same EHD criteria but were discharged later than 48 hours.
The stay in almost half (48%) the early discharge group was 24 hours or less, according to the study, published Dec. 13 in the Journal of the American College of Cardiology.
“We’ve shown that if we use appropriate risk criteria and instigate the appropriate, safe follow-up that it’s safe to select and discharge low-risk patients at an earlier time period, such as 24 hours,” senior author Daniel A. Jones, PhD, Barts Heart Centre, London, this news organization.
“Obviously, it’s one center in one city in the world,” he said. “Whether it’s applicable at other heart site centers, I believe it is, but I think we need more data to be able to change guidelines.”
Current European Society of Cardiology guidelines say that select patients should be considered for early discharge 48 to 72 hours after STEMI, but the COVID-19 pandemic incentivized the team to try and push that window.
“The COVID pandemic essentially brought a focus on resources, on minimizing the risk to our patient population in terms of catching COVID within hospital,” he said. “It became clear that to maintain the heart site service, we probably needed to get people out a bit quicker than we did before, so we came up with this pathway.”
Between March 2020 and June 2021, 600 patients presenting with STEMI were entered into the EHD pathway if they met the following pre-existing criteria for 48- to 72-hour discharge:
- Left ventricular ejection fraction 40% or greater
- Successful primary PCI with TIMI flow grade 3
- Absence of bystander disease requiring inpatient revascularization
- No recurrent ischemic symptoms
- No heart failure
- No significant arrhythmias
- No hemodynamic instability
- No significant comorbidity
- Suitable social circumstances for early discharge
The patients were given cardiac rehabilitation counseling over the phone within 48 hours and blood pressure machines if not available at home. At weeks 2 and 8, they spoke virtually with a dedicated cardiology advanced care practitioner who up-titrated medications and answered any questions. At week 12, they were seen by an interventional cardiologist or at a high-risk prevention clinic.
Their mean age was 59.2 years, 86% were male, the median symptom-to-balloon time was 80 minutes, and median door-to-balloon time was 50 minutes.
The early discharge patients were compared with 700 historic control subjects who met the EHD criteria and were discharged after 48 hours from Oct. 2018 to June 2021 and 560 patients discharged on standard-care pathways between April 2020 and June 2021.
Those discharged after 48 hours were more likely to have an anterior MI, multivessel disease, and multivessel PCI.
Comparable outcomes
The median length of stay was 24.6 hours (minimum 17 hours, maximum 40 hours) for the EHD group, 56.1 hours for historic control subjects, and 78.9 hours for the standard-care group.
The introduction of the EHD pathway significantly reduced the overall length of stay for all STEMI patients compared with the pre-pathway period of Oct. 2018 to March 2020 (median, 3 vs. 2 days; P < .0001).
Length of stay varied among patients; however, 420 patients stayed 1 less night in the hospital with the remaining patients staying about 8 to 12 fewer hours, resulting in approximate savings of £450,000, the authors note.
Over a median follow-up of 271 days, there were no cardiovascular deaths, two deaths from COVID-19, and a MACE rate of 1.2% (two deaths, three unscheduled revascularizations, and two further MI presentations) in the EHD group. That compares with a 0.7% mortality and 1.9% rate of MACE among historic control subjects, neither of which were significantly different.
There was also no difference in mortality (0.34% vs. 0.69%; P = .410) or MACE (1.2% vs. 1.9%; P = .342) among 560 pairs of propensity-matched EHD patients and historic control subjects.
Mortality was 4.1% in the standard-care group; cardiovascular mortality was 2.2%, and the rate of MACE was 8.6%.
When patients were surveyed, 85% were “satisfied” or “very satisfied” with the EHD pathway, whereas 73% of control and standard-care patients were satisfied with their care. Three-fourths of EHD patients also reported saving money and 62.5% saved time off work because of the virtual follow-up.
Judgment calls
“They didn’t really tell us much about the patients who didn’t qualify into this ultra–low-risk group but, obviously, it’s highly selected,” Cindy Grines, MD, Northside Hospital Cardiovascular Institute, Lawrenceville, Georgia, said in an interview. “In the U.S., you don’t get those chest pain onset-to-reperfusion in 80 minutes. So that was really kind of shocking.”
It also suggests that early discharge was applied to patients who may have had minimal myocardial damage from the STEMI, she suggested. “Even in their own hospital system, a lot of patients who met the criteria on paper were kept longer than 48 hours. So a lot of it’s a judgment call.”
Additional red flags where physicians may overrule the early discharge protocol are very late perfusion, advanced age, severe renal insufficiency, profound anemia, cardiac arrest requiring more than brief resuscitation, bleeding complications, or symptomatic coronavirus, Dr. Grines and J. Jeffrey Marshall, MD, also from Northside, observe in an accompanying editorial.
About 60% of patients were suitable for the EHD pathway, Dr. Jones said. “Typically, they are quite low risk, but we still had four in 10 anterior infarct, and about 25% had left ventricular function between 40% and 45%. So even though the majority are low risk, there are patients in there that you would consider to have had a decent infarct.”
“I think this is applicable to patients at most centers, and probably anywhere between a third to a fifth of all patients presenting to heart centers would be suitable for this discharge pathway,” he said.
Dr. Grines said the pathway is “definitely feasible” but there aren’t enough patients studied to know with 100% certainty whether it’s safe. A single observational study also isn’t enough to change guidelines, which in the United States do not comment on length of stay.
“In the ultra-low-risk patients – such as the ones where you got them in very early and you almost aborted the infarct or if it was a very small infarct – you can kind of treat them like an unstable angina patient, where you can do the PCI and potentially discharge them in 24 hours,” Dr. Grines said. “I think most of us might agree on that.”
“The other thing you have to weigh is the risk/benefit ratio,” she said. “If you have no beds available, you end up rationing care to some extent. So if you have a patient that’s otherwise doing well after a very small MI and have an emergency room full of people that need to be admitted and they’re sicker, then you end up making those judgment calls.”
Dr. Jones pointed out that current guidelines are based largely on observational data and that the team is planning to pilot the EHD pathway at five to 10 centers around the United Kingdom or potentially in Europe or the United States.
“This is an area where a [randomized controlled trial] RCT would be expensive, whereas a well-coordinated multicenter registry would probably provide enough information to change guidelines,” he said. “We’re not suggesting that every STEMI patient is suitable, but people that are low risk that you would already be considering for early discharge I think can go a bit quicker.”
Dr. Jones has received funding from the Barts Charity and financial support for blood pressure machines from the Barts Guild. First author Krishnaraj Rathod has received funding from the National Institute for Health and Research in the form of an Academic Clinical Lectureship. All other authors, Dr. Grines, and Dr. Marshall report having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Highly selected low-risk patients can be safely sent home about 24 hours after successful percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) when supported by intense, multidisciplinary virtual follow-up, a prospective study suggests for the first time.
The risk for major adverse cardiac events (MACE) in STEMI patients following an early hospital discharge (EHD) pathway was similar at 9 months to that seen for propensity-matched historic control subjects who met the same EHD criteria but were discharged later than 48 hours.
The stay in almost half (48%) the early discharge group was 24 hours or less, according to the study, published Dec. 13 in the Journal of the American College of Cardiology.
“We’ve shown that if we use appropriate risk criteria and instigate the appropriate, safe follow-up that it’s safe to select and discharge low-risk patients at an earlier time period, such as 24 hours,” senior author Daniel A. Jones, PhD, Barts Heart Centre, London, this news organization.
“Obviously, it’s one center in one city in the world,” he said. “Whether it’s applicable at other heart site centers, I believe it is, but I think we need more data to be able to change guidelines.”
Current European Society of Cardiology guidelines say that select patients should be considered for early discharge 48 to 72 hours after STEMI, but the COVID-19 pandemic incentivized the team to try and push that window.
“The COVID pandemic essentially brought a focus on resources, on minimizing the risk to our patient population in terms of catching COVID within hospital,” he said. “It became clear that to maintain the heart site service, we probably needed to get people out a bit quicker than we did before, so we came up with this pathway.”
Between March 2020 and June 2021, 600 patients presenting with STEMI were entered into the EHD pathway if they met the following pre-existing criteria for 48- to 72-hour discharge:
- Left ventricular ejection fraction 40% or greater
- Successful primary PCI with TIMI flow grade 3
- Absence of bystander disease requiring inpatient revascularization
- No recurrent ischemic symptoms
- No heart failure
- No significant arrhythmias
- No hemodynamic instability
- No significant comorbidity
- Suitable social circumstances for early discharge
The patients were given cardiac rehabilitation counseling over the phone within 48 hours and blood pressure machines if not available at home. At weeks 2 and 8, they spoke virtually with a dedicated cardiology advanced care practitioner who up-titrated medications and answered any questions. At week 12, they were seen by an interventional cardiologist or at a high-risk prevention clinic.
Their mean age was 59.2 years, 86% were male, the median symptom-to-balloon time was 80 minutes, and median door-to-balloon time was 50 minutes.
The early discharge patients were compared with 700 historic control subjects who met the EHD criteria and were discharged after 48 hours from Oct. 2018 to June 2021 and 560 patients discharged on standard-care pathways between April 2020 and June 2021.
Those discharged after 48 hours were more likely to have an anterior MI, multivessel disease, and multivessel PCI.
Comparable outcomes
The median length of stay was 24.6 hours (minimum 17 hours, maximum 40 hours) for the EHD group, 56.1 hours for historic control subjects, and 78.9 hours for the standard-care group.
The introduction of the EHD pathway significantly reduced the overall length of stay for all STEMI patients compared with the pre-pathway period of Oct. 2018 to March 2020 (median, 3 vs. 2 days; P < .0001).
Length of stay varied among patients; however, 420 patients stayed 1 less night in the hospital with the remaining patients staying about 8 to 12 fewer hours, resulting in approximate savings of £450,000, the authors note.
Over a median follow-up of 271 days, there were no cardiovascular deaths, two deaths from COVID-19, and a MACE rate of 1.2% (two deaths, three unscheduled revascularizations, and two further MI presentations) in the EHD group. That compares with a 0.7% mortality and 1.9% rate of MACE among historic control subjects, neither of which were significantly different.
There was also no difference in mortality (0.34% vs. 0.69%; P = .410) or MACE (1.2% vs. 1.9%; P = .342) among 560 pairs of propensity-matched EHD patients and historic control subjects.
Mortality was 4.1% in the standard-care group; cardiovascular mortality was 2.2%, and the rate of MACE was 8.6%.
When patients were surveyed, 85% were “satisfied” or “very satisfied” with the EHD pathway, whereas 73% of control and standard-care patients were satisfied with their care. Three-fourths of EHD patients also reported saving money and 62.5% saved time off work because of the virtual follow-up.
Judgment calls
“They didn’t really tell us much about the patients who didn’t qualify into this ultra–low-risk group but, obviously, it’s highly selected,” Cindy Grines, MD, Northside Hospital Cardiovascular Institute, Lawrenceville, Georgia, said in an interview. “In the U.S., you don’t get those chest pain onset-to-reperfusion in 80 minutes. So that was really kind of shocking.”
It also suggests that early discharge was applied to patients who may have had minimal myocardial damage from the STEMI, she suggested. “Even in their own hospital system, a lot of patients who met the criteria on paper were kept longer than 48 hours. So a lot of it’s a judgment call.”
Additional red flags where physicians may overrule the early discharge protocol are very late perfusion, advanced age, severe renal insufficiency, profound anemia, cardiac arrest requiring more than brief resuscitation, bleeding complications, or symptomatic coronavirus, Dr. Grines and J. Jeffrey Marshall, MD, also from Northside, observe in an accompanying editorial.
About 60% of patients were suitable for the EHD pathway, Dr. Jones said. “Typically, they are quite low risk, but we still had four in 10 anterior infarct, and about 25% had left ventricular function between 40% and 45%. So even though the majority are low risk, there are patients in there that you would consider to have had a decent infarct.”
“I think this is applicable to patients at most centers, and probably anywhere between a third to a fifth of all patients presenting to heart centers would be suitable for this discharge pathway,” he said.
Dr. Grines said the pathway is “definitely feasible” but there aren’t enough patients studied to know with 100% certainty whether it’s safe. A single observational study also isn’t enough to change guidelines, which in the United States do not comment on length of stay.
“In the ultra-low-risk patients – such as the ones where you got them in very early and you almost aborted the infarct or if it was a very small infarct – you can kind of treat them like an unstable angina patient, where you can do the PCI and potentially discharge them in 24 hours,” Dr. Grines said. “I think most of us might agree on that.”
“The other thing you have to weigh is the risk/benefit ratio,” she said. “If you have no beds available, you end up rationing care to some extent. So if you have a patient that’s otherwise doing well after a very small MI and have an emergency room full of people that need to be admitted and they’re sicker, then you end up making those judgment calls.”
Dr. Jones pointed out that current guidelines are based largely on observational data and that the team is planning to pilot the EHD pathway at five to 10 centers around the United Kingdom or potentially in Europe or the United States.
“This is an area where a [randomized controlled trial] RCT would be expensive, whereas a well-coordinated multicenter registry would probably provide enough information to change guidelines,” he said. “We’re not suggesting that every STEMI patient is suitable, but people that are low risk that you would already be considering for early discharge I think can go a bit quicker.”
Dr. Jones has received funding from the Barts Charity and financial support for blood pressure machines from the Barts Guild. First author Krishnaraj Rathod has received funding from the National Institute for Health and Research in the form of an Academic Clinical Lectureship. All other authors, Dr. Grines, and Dr. Marshall report having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
CRP elevated in adults with AD and sleep disturbance
and mortality, results from a large cohort analysis showed.
“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”
To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.
The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).
To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”
Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).
“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.
Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”
“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”
Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.
A version of this article first appeared on Medscape.com.
and mortality, results from a large cohort analysis showed.
“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”
To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.
The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).
To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”
Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).
“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.
Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”
“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”
Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.
A version of this article first appeared on Medscape.com.
and mortality, results from a large cohort analysis showed.
“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”
To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.
The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).
To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”
Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).
“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.
Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”
“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”
Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.
A version of this article first appeared on Medscape.com.
More Americans skipping medical care because of cost, survey says
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.