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Tuesday, October 22, 2019
Moderna’s mRNA-3927 Fast Track’d for rare metabolic disorder
The FDA has designated Moderna’s (NASDAQ:MRNA) mRNA-3927 for Fast Track review for the treatment of propionic acidemia, a rare inherited disorder in which the body cannot properly process certain parts of fats and proteins.
Clinical development is set to begin following the agency’s sign-off on the IND less than a month ago.
Fast Track status provides for more frequent
interaction with the FDA review team and a rolling review of the
marketing application.
https://seekingalpha.com/news/3508073-modernas-mrnaminus-3927-fast-trackd-rare-metabolic-disorderNo Solid Evidence to Support SSRIs in Autism
The selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac, Eli Lilly) appears to provide no benefit in treating obsessive-compulsive symptoms in children with autism spectrum disorders (ASDs).
Results of a randomized trial showed that although the SSRI fluoxetine reduced obsessive-compulsive behaviors compared with placebo, the difference was statistically nonsignificant when sex, verbal ability, and baseline imbalances were considered.
“Clinicians and families should be cautious about the use of these medications where, to-date, there has been no published evidence of their effectiveness in children and young people with ASDs,” lead author Dinah S. Reddihough, MD, a pediatrician at the Royal Children’s Hospital, and Research Fellow at the Murdoch Children’s Research Institute, Melbourne, Australia, told Medscape Medical News.
The findings were published online today in the Journal of the American Medical Association.
Despite inconclusive evidence that they are effective, antidepressants are prescribed for up to one third of children and adolescents with ASDs.
The rationale for prescribing these medications in this population is based on evidence that serotonin plays a contributory role in the pathophysiology of ASDs.
There is support from genetic, biological, and neuroimaging studies
indicating that individuals with ASDs have higher serotonin levels than
those without such disorders, the authors note.
To examine the efficacy of SSRIs, the investigators conducted the Fluoxetine for Autism Behaviors (FAB) study. The trial included 146 children and adolescents aged 7.5 to 18 years (mean age 11.2 years; 85% male) at three sites.
The original minimum age for the trial was 8 years but was lowered because recruitment proved difficult. It took 7 years to complete the trial.
“Many families did not want to risk being randomized to the placebo group,” said Reddihough. “Fluoxetine was available off-label from community pediatricians, making it difficult for families to understand why they should participate in a trial.”
Study participants had “significant problems” with obsessive-compulsive behaviors, with a total score of six or more on the Children’s Yale-Brown Obsessive Compulsive Scale–Modified for pervasive developmental disorders (CYBOCS-PDD), said Reddihough.
Participants were randomly assigned to receive fluoxetine or placebo. The once daily dose of the active drug was tied to weight, starting at 4 mg/day (for participants under 40 kg [88 lb]) or 8 mg/day (for those 40 or more kg) for the first week and was then titrated weekly over 3 weeks. The maximum dose was 20 mg/day to 30 mg/day. After a follow-up assessment at 16 weeks, the medication was tapered over 4 weeks.
The CYBOCS-PDD was selected as the primary outcome based on findings of a previous trial of fluvoxamine (Luvox,
ANI Pharmaceuticals), an SSRI used primarily for treatment of
obsessive–compulsive disorder, in children with ASDs. That study showed
that the CYBOCS was sensitive to change across the treatment period,
said Reddihough.
Secondary outcomes included differences in scores on a number of rating scales, among them the Repetitive Behavior Scale-Revised (RBS) and the Aberrant Behavior Checklist-Community Version (ABC), which measures inappropriate behaviors in individuals with developmental or intellectual impairments.
The placebo group had worse baseline scores on the RBS and the ABC lethargy scale than the fluoxetine groups.
Many participants — 41% in the fluoxetine group and 30% in the
placebo group — did not complete the trial. Reddihough noted that
families of children with autism have high levels of maternal depression and family stress.
“Adhering to a treatment regimen over 16 weeks would likely have been difficult for many families, particularly if they felt that the medication was not of benefit,” she said.
Results showed that from baseline to study end, CYBOCS-PDD scores were lowered more in the fluoxetine than in the placebo groups (from 12.80 to 9.02 compared to 13.13 to 10.89; mean difference of −2.01; 95% confidence interval [CI], −3.77 to −0.25; P = .03).
However, this difference became nonsignificant after controlling for
sex, verbal ability, baseline measure of the CYBOCS-PDD, and baseline
differences in the RBS and ABC lethargy subscale (mean difference −1.17;
95% CI, −3.01 to 0.67; P = .21).
An additional analysis using multiple imputation for missing data was also not statistically significant (mean difference −1.82; 95% CI, −3.71 to 0.06; P = .06).
In total, 45% of the fluoxetine group and 42% of the placebo group experienced adverse events. The most common of these were mood disturbance, particularly irritability, gastrointestinal problems such as nausea and diarrhea, and sleep disorders. Two participants in the placebo group and none in the fluoxetine group experienced serious adverse events.
Although the evidence “is not strong enough” to recommend fluoxetine as a treatment for this study population, “we can’t exclude that it is helpful for some individual children. More research is needed,” said Reddihough.”
While conducting drug studies in children and adolescents with autism is “extremely difficult,” they still need to be done, she added.
King noted that the baseline mean score on the CYBOCS-PDD was only 12.8 in the fluoxetine-treated group. With 6 being the minimum entry score, the study population may not have been “enriched for children for whom repetitive behaviors were specific or significant problems,” he notes.
Using entry criteria that did not produce a study cohort of children at greatest risk “may have made it more difficult to find a therapeutic signal,” he added.
King also noted that the lack of between-group differences in adverse events could suggest that the dosing of the treatment may have been too low.
Additional rigorous studies are needed, King writes, both to identify
other potential treatments for core symptoms and to determine whether
clinical indications other than repetitive behaviors might account for
the persistent widespread use of SSRIs in ASD.
In addition to the CYBOCS, the inclusion of other outcome scales “more specific” to autistic children in the primary analysis may have produced different results, said Shapiro, who was not involved with the current study.
Although the study was “pretty long,” researchers may want to look at
longer-term effects, said Shapiro. She noted that when treating
children not on the autism spectrum with an SSRI for anxiety, OCD, or
other symptoms, “we usually do it for more than 16 weeks; we usually do
it for 6 months to a year or even longer.”
Clinicians continue to use SSRIs in children with autism, even without solid evidence, because they simply “don’t have many tricks in their bag,” said Shapiro. “We don’t have many proven useful treatments.”
She added that in many cases, other medications have too many unacceptable side effects.
Shapiro stressed that as children grow, they pass through
developmental stages and experience changes in hormones, so their
symptoms “tend to wax and wane,” and their behaviors change, said
Shapiro.
“You may have to change medications at different times to get good results,” she added.
While Shapiro said she is pleased to see studies like the current one, “the door shouldn’t be closed.”
“We need more funding for studies to look at different treatment strategies for children with autism,” she added.
The study was supported by Australia’s National Health and Medical Research Council, the Royal Children’s Hospital Foundation in Melbourne, the Victorian government’s Operational Infrastructure Support Program, and the Murdoch Children’s Research Institute. Reddihough, King, and Shapiro have disclosed no relevant financial relationships.
JAMA. Published online October 22, 2019. Full text, Editorial
https://www.medscape.com/viewarticle/920150#vp_1
Results of a randomized trial showed that although the SSRI fluoxetine reduced obsessive-compulsive behaviors compared with placebo, the difference was statistically nonsignificant when sex, verbal ability, and baseline imbalances were considered.
“Clinicians and families should be cautious about the use of these medications where, to-date, there has been no published evidence of their effectiveness in children and young people with ASDs,” lead author Dinah S. Reddihough, MD, a pediatrician at the Royal Children’s Hospital, and Research Fellow at the Murdoch Children’s Research Institute, Melbourne, Australia, told Medscape Medical News.
The findings were published online today in the Journal of the American Medical Association.
Commonly Prescribed
Autism is characterized by restricted and repetitive interests and behaviors that can include stereotypic motor movements, ritualistic behaviors, and difficulty coping with change. This often manifests as anxiety, irritability, aggression, and self-injury, which frequently interferes with everyday functioning.Despite inconclusive evidence that they are effective, antidepressants are prescribed for up to one third of children and adolescents with ASDs.
The rationale for prescribing these medications in this population is based on evidence that serotonin plays a contributory role in the pathophysiology of ASDs.
To examine the efficacy of SSRIs, the investigators conducted the Fluoxetine for Autism Behaviors (FAB) study. The trial included 146 children and adolescents aged 7.5 to 18 years (mean age 11.2 years; 85% male) at three sites.
The original minimum age for the trial was 8 years but was lowered because recruitment proved difficult. It took 7 years to complete the trial.
“Many families did not want to risk being randomized to the placebo group,” said Reddihough. “Fluoxetine was available off-label from community pediatricians, making it difficult for families to understand why they should participate in a trial.”
Study participants had “significant problems” with obsessive-compulsive behaviors, with a total score of six or more on the Children’s Yale-Brown Obsessive Compulsive Scale–Modified for pervasive developmental disorders (CYBOCS-PDD), said Reddihough.
Participants were randomly assigned to receive fluoxetine or placebo. The once daily dose of the active drug was tied to weight, starting at 4 mg/day (for participants under 40 kg [88 lb]) or 8 mg/day (for those 40 or more kg) for the first week and was then titrated weekly over 3 weeks. The maximum dose was 20 mg/day to 30 mg/day. After a follow-up assessment at 16 weeks, the medication was tapered over 4 weeks.
High Dropout Rate
The primary outcome was the difference in total score on the CYBOCS-PDD. This scale includes a checklist of possible obsessions and compulsions, rated from 0 to 4 across five items, with a focus on stereotypic and complex behaviors typically associated with ASDs. The total score can range from 0 to 20, with higher scores indicating higher levels of maladaptive behaviors.Secondary outcomes included differences in scores on a number of rating scales, among them the Repetitive Behavior Scale-Revised (RBS) and the Aberrant Behavior Checklist-Community Version (ABC), which measures inappropriate behaviors in individuals with developmental or intellectual impairments.
The placebo group had worse baseline scores on the RBS and the ABC lethargy scale than the fluoxetine groups.
“Adhering to a treatment regimen over 16 weeks would likely have been difficult for many families, particularly if they felt that the medication was not of benefit,” she said.
Results showed that from baseline to study end, CYBOCS-PDD scores were lowered more in the fluoxetine than in the placebo groups (from 12.80 to 9.02 compared to 13.13 to 10.89; mean difference of −2.01; 95% confidence interval [CI], −3.77 to −0.25; P = .03).
An additional analysis using multiple imputation for missing data was also not statistically significant (mean difference −1.82; 95% CI, −3.71 to 0.06; P = .06).
In total, 45% of the fluoxetine group and 42% of the placebo group experienced adverse events. The most common of these were mood disturbance, particularly irritability, gastrointestinal problems such as nausea and diarrhea, and sleep disorders. Two participants in the placebo group and none in the fluoxetine group experienced serious adverse events.
Although the evidence “is not strong enough” to recommend fluoxetine as a treatment for this study population, “we can’t exclude that it is helpful for some individual children. More research is needed,” said Reddihough.”
While conducting drug studies in children and adolescents with autism is “extremely difficult,” they still need to be done, she added.
No Added Value
In an accompanying editorial, Bryan H. King, MD, from the Department of Psychiatry at the University of California San Francisco’s Weill Institute for Neurosciences, said the study outcome “contributes new evidence that SSRIs do not add any value over placebo for repetitive behaviors in children and adolescents with ASD.”King noted that the baseline mean score on the CYBOCS-PDD was only 12.8 in the fluoxetine-treated group. With 6 being the minimum entry score, the study population may not have been “enriched for children for whom repetitive behaviors were specific or significant problems,” he notes.
Using entry criteria that did not produce a study cohort of children at greatest risk “may have made it more difficult to find a therapeutic signal,” he added.
King also noted that the lack of between-group differences in adverse events could suggest that the dosing of the treatment may have been too low.
Don’t Close the Door
Commenting for Medscape Medical News, Gabrielle L. Shapiro, MD, clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City, and chair of the American Psychiatric Association (APA) council on children, adolescents and families, described the study as “somewhat flawed.”In addition to the CYBOCS, the inclusion of other outcome scales “more specific” to autistic children in the primary analysis may have produced different results, said Shapiro, who was not involved with the current study.
Clinicians continue to use SSRIs in children with autism, even without solid evidence, because they simply “don’t have many tricks in their bag,” said Shapiro. “We don’t have many proven useful treatments.”
She added that in many cases, other medications have too many unacceptable side effects.
“You may have to change medications at different times to get good results,” she added.
While Shapiro said she is pleased to see studies like the current one, “the door shouldn’t be closed.”
“We need more funding for studies to look at different treatment strategies for children with autism,” she added.
The study was supported by Australia’s National Health and Medical Research Council, the Royal Children’s Hospital Foundation in Melbourne, the Victorian government’s Operational Infrastructure Support Program, and the Murdoch Children’s Research Institute. Reddihough, King, and Shapiro have disclosed no relevant financial relationships.
JAMA. Published online October 22, 2019. Full text, Editorial
https://www.medscape.com/viewarticle/920150#vp_1
Trigeminal Nerve Stimulation Promising for ADHD in Kids
Trigeminal nerve stimulation (TNS) is safe and effective in
alleviating symptoms of attention-deficit/hyperactivity disorder (ADHD)
in children, a new study suggests.
In the blinded, sham-controlled trial, which was funded by the National Institutes of Health, use of TNS resulted in an estimated treatment effect comparable to that of nonstimulant medications. The investigators note that additional research is necessary to determine the durability of treatment response, as well as the potential impact of sustained TNS on brain development.
“As far as I know, this is the first sham-controlled study of neuromodulation in youth, and the first study that showed positive results from a minimal-risk neuromodulation technique,” said James J. McGough, MD, of the Ronald Reagan UCLA Medical Center in Los Angeles, California.
“Patients’ ADHD symptoms improved to about the same degree that we see with nonstimulant medications, and those improvements actually correlated with positive changes in spectral power as well,” he added.
The findings were presented here at the American Academy of Child & Adolescent Psychiatry (AACAP) 66th Annual Meeting.
TNS may prove to be a welcome addition to current treatment options in childhood ADHD, McGough noted.
“Our current approach to ADHD predominantly relies on medication.
Acutely, we do pretty well. But medications also have their problems,
such as side effects,” he said.
“More importantly, no parent wants to hear that they have to give their child a pill every day. This has really led to an ongoing interest in developing nonmedication, low-risk therapies to treat the disorder,” he added.
To gain more insight into the potential efficacy of TNS in this population, the investigators enrolled 62 children aged 8 to 12 years with ADHD into the study. ADHD was diagnosed on the basis of results of the Kiddie Schedule for Affective Disorders and Schizophrenia interview. All the participants had full-scale IQ scores of 85. They were randomly assigned to receive 4 weeks of nightly treatment with either active or sham TNS, after which 1 week passed without intervention.
The children underwent weekly assessments with the clinician-administered ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression (CGI) scale. Resting-state quantitative electroencephalography was performed at baseline and at week 4.
The results were promising. Investigators found that ADHD-RS total scores indicated significant group-by-time interactions at week 4 (F = 8.12; df = 1/228; P = .005).
“Interestingly, we saw a parallel decline in symptoms in both the sham and active groups in the first week. But after that, there was a separation of symptoms: while the sham group flattened out, the active group actually continued improvement over the course of the 4 weeks,” said McGough.
He noted that at the end of the fourth week, the Cohen’s effect size value was 0.5, which is about the same effect that is seen with nonstimulant medications in ADHD.
“That was a robust and wonderful finding, suggesting that TNS is about as effective as, say, guanfacine or clonidine,” he added.
“This suggests that even a week after cessation of therapy, there is still a positive effect on ADHD in the TNS group,” McGough said.
The investigators also found that improvement in CGI favored the active-treatment group (X2 = 8.75; df = 1/168; P = .003). The number needed to treat was three.
“We saw a stable placebo response in the sham group but increasing responses over time in the active group, suggesting that with ongoing stimulation there may be an increase of effect,” he said.
Similarly, resting-state quantitative electroencephalography demonstrated increased spectral power in the right frontal and frontal midline frequency bands with active TNS.
“I think this suggests that what we’re measuring here isn’t simply a
subjective placebo effect. We’re actually showing with a biological test
that there were differences between the two groups,” McGough said.
No meaningful adverse events occurred in either group.
“And that’s just what Dr McGough and his colleagues have done. They continue to build on this vision quest to figure out how we can help the children who suffer with this most common condition,” he added.
McGough noted that this study is only a first step in a lengthy research chain.
“Certainly this work should be replicated in larger samples and at multiple sites,” he concluded. “And very importantly, we need to have a better understanding of who is going to respond to this and what the long-term effects might be,” he said.
J Am Acad Child Adolesc Psychiatry. 2019;58:S125. Abstract
American Academy of Child & Adolescent Psychiatry (AACAP) 66th Annual Meeting: Abstract 1.2, presented October 17, 2019.
https://www.medscape.com/viewarticle/920157#vp_1
In the blinded, sham-controlled trial, which was funded by the National Institutes of Health, use of TNS resulted in an estimated treatment effect comparable to that of nonstimulant medications. The investigators note that additional research is necessary to determine the durability of treatment response, as well as the potential impact of sustained TNS on brain development.
“As far as I know, this is the first sham-controlled study of neuromodulation in youth, and the first study that showed positive results from a minimal-risk neuromodulation technique,” said James J. McGough, MD, of the Ronald Reagan UCLA Medical Center in Los Angeles, California.
“Patients’ ADHD symptoms improved to about the same degree that we see with nonstimulant medications, and those improvements actually correlated with positive changes in spectral power as well,” he added.
The findings were presented here at the American Academy of Child & Adolescent Psychiatry (AACAP) 66th Annual Meeting.
“Robust and Wonderful Finding”
TNS is a noninvasive neuromodulation technique that poses minimal risk to patients. Although the technology has not been subject to much research in children with ADHD, a previous unblinded, open study showed its potential benefit in this population.TNS may prove to be a welcome addition to current treatment options in childhood ADHD, McGough noted.
“More importantly, no parent wants to hear that they have to give their child a pill every day. This has really led to an ongoing interest in developing nonmedication, low-risk therapies to treat the disorder,” he added.
To gain more insight into the potential efficacy of TNS in this population, the investigators enrolled 62 children aged 8 to 12 years with ADHD into the study. ADHD was diagnosed on the basis of results of the Kiddie Schedule for Affective Disorders and Schizophrenia interview. All the participants had full-scale IQ scores of 85. They were randomly assigned to receive 4 weeks of nightly treatment with either active or sham TNS, after which 1 week passed without intervention.
The children underwent weekly assessments with the clinician-administered ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression (CGI) scale. Resting-state quantitative electroencephalography was performed at baseline and at week 4.
The results were promising. Investigators found that ADHD-RS total scores indicated significant group-by-time interactions at week 4 (F = 8.12; df = 1/228; P = .005).
“Interestingly, we saw a parallel decline in symptoms in both the sham and active groups in the first week. But after that, there was a separation of symptoms: while the sham group flattened out, the active group actually continued improvement over the course of the 4 weeks,” said McGough.
He noted that at the end of the fourth week, the Cohen’s effect size value was 0.5, which is about the same effect that is seen with nonstimulant medications in ADHD.
Durable Effect?
In the fifth week of the study ― after treatment had been stopped ― there was a parallel deterioration of symptoms in both groups. Nevertheless, the Cohen’s effect size at week 5 remained approximately 0.5.“This suggests that even a week after cessation of therapy, there is still a positive effect on ADHD in the TNS group,” McGough said.
“We saw a stable placebo response in the sham group but increasing responses over time in the active group, suggesting that with ongoing stimulation there may be an increase of effect,” he said.
Similarly, resting-state quantitative electroencephalography demonstrated increased spectral power in the right frontal and frontal midline frequency bands with active TNS.
No meaningful adverse events occurred in either group.
A First Step
“These researchers took on the disorder that child psychiatrists feel most comfortable diagnosing and treating, yet silently admit that they really don’t know how to diagnose and treat it,” said Jim Hudziak, MD, of the University of Vermont in Burlington. “But because it’s our hallmark disorder, we need to continue to develop our expertise in this area.“And that’s just what Dr McGough and his colleagues have done. They continue to build on this vision quest to figure out how we can help the children who suffer with this most common condition,” he added.
McGough noted that this study is only a first step in a lengthy research chain.
“Certainly this work should be replicated in larger samples and at multiple sites,” he concluded. “And very importantly, we need to have a better understanding of who is going to respond to this and what the long-term effects might be,” he said.
J Am Acad Child Adolesc Psychiatry. 2019;58:S125. Abstract
American Academy of Child & Adolescent Psychiatry (AACAP) 66th Annual Meeting: Abstract 1.2, presented October 17, 2019.
https://www.medscape.com/viewarticle/920157#vp_1
Warren ‘still weighing Medicare for All financing options’
White House hopeful Elizabeth Warren is taking heat from her
Democratic rivals for her demurrals when asked whether her Medicare for
All healthcare plan would require raising taxes on middle-class
households.
One explanation, according to sources close to Warren’s campaign, is
that the U.S. senator from Massachusetts is still considering financing
options and at least one under review does not include a middle-class
tax hike.
“I’ve been working for a long time on this question about what the costs will be and how to pay for it and I’m getting close. It’s just got a little more work that it needs on it before it’s ready,” Warren told reporters in Indianola, Iowa, on Sunday, adding that she will be “ready to put out a plan soon on exactly what the costs will be.”
How best to expand health insurance coverage has become one of the defining issues in the Democratic nominating contest to take on Republican President Donald Trump in November 2020.
Progressives Warren and U.S. Senator Bernie Sanders favor expanding the government’s existing Medicare program for individuals 65 years and older to cover all Americans.
Moderates such as South Bend, Indiana Mayor Pete Buttigieg and former Vice President Joe Biden favor a more incremental opt-in approach that would have a lower price tag but cover fewer individuals.
How to pay for a single-payer system that could cost as much as $34 trillion over 10 years, according to a study released last week by the liberal Urban Institute, has become the main point of contention between the progressive and moderate Democratic White House candidates.
Warren has repeatedly said that she “will not sign a bill into law that does not lower costs for middle-class families.” Her go-to answer when asked about paying for Medicare for All is that overall costs for families will go down.
Though Warren has become known for a voluminous stable of detailed policy proposals and “I have a plan for that” has become the catch phrase of her White House campaign, her initial healthcare plan was comparatively light on details. She has said “I’m with Bernie on Medicare for All” when asked about her stance.
Sanders introduced a Medicare for All bill in the Senate that would
transition the U.S. to a single-payer system. But the legislation, which
was co-sponsored by Warren and fellow 2020 rivals Senators Cory Booker
and Kamala Harris, did not detail how to pay for the proposal. Sanders
released a five-page explainer of financing options in conjunction with
the bill’s introduction.
Buttigieg on the campaign trail has slammed Warren for not detailing how she would pay for Medicare for all.
Sanders is one reason why Warren has yet to address whether middle-class tax rates would go up. “She’s trying to be respectful of his genuine thought leadership here,” said one progressive activist close to the campaign.
Another is that her campaign has solicited input from experts on a variety of Medicare for All financing options, including at least one that would not necessitate a middle-class tax hike.
Robert Pollin, an economics professor at the University of Massachusetts-Amherst who studied financing options for Sanders’ 2017 Medicare for All bill and has advised both his and Warren’s campaigns, estimated that a single-payer healthcare system would have cost the government $37.8 trillion over 2017-2026. New sources of revenue would be needed to cover about $13.5 trillion of that, he estimated.
Pollin said in an interview that his research shows a 1.8% business tax on gross receipts, a 3.75% federal sales tax on non-essential goods and a 0.38% tax on wealth above $1 million would respectively generate about $600 billion, $200 billion and $200 billion annually. That, along with cost savings associated with a single-payer system, would account for the $13.5 trillion needed.
He said he designed his plan to minimize impact on consumer behavior, keep the burden on employers to cover some healthcare costs via the business tax and that lower-income households would be exempt from the sales-tax on non-essential goods.
A middle-class household with an annual income of $60,000 would pay about $900 a year in sales tax. Depending on current healthcare costs, however, it would save about $2,000 to $8,000 each year, he said.
Pollin said his discussions with Warren’s campaign are ongoing and its questions have been “very diligent.”
“The notion that Elizabeth Warren’s staff or Elizabeth Warren herself has neglected this is very false. They’re trying to be very, very careful,” he said.
https://www.reuters.com/article/us-usa-election-warren-medicare/democratic-2020-hopeful-warren-still-weighing-medicare-for-all-financing-options-idUSKBN1X0278
“I’ve been working for a long time on this question about what the costs will be and how to pay for it and I’m getting close. It’s just got a little more work that it needs on it before it’s ready,” Warren told reporters in Indianola, Iowa, on Sunday, adding that she will be “ready to put out a plan soon on exactly what the costs will be.”
How best to expand health insurance coverage has become one of the defining issues in the Democratic nominating contest to take on Republican President Donald Trump in November 2020.
Progressives Warren and U.S. Senator Bernie Sanders favor expanding the government’s existing Medicare program for individuals 65 years and older to cover all Americans.
Moderates such as South Bend, Indiana Mayor Pete Buttigieg and former Vice President Joe Biden favor a more incremental opt-in approach that would have a lower price tag but cover fewer individuals.
How to pay for a single-payer system that could cost as much as $34 trillion over 10 years, according to a study released last week by the liberal Urban Institute, has become the main point of contention between the progressive and moderate Democratic White House candidates.
Warren has repeatedly said that she “will not sign a bill into law that does not lower costs for middle-class families.” Her go-to answer when asked about paying for Medicare for All is that overall costs for families will go down.
Though Warren has become known for a voluminous stable of detailed policy proposals and “I have a plan for that” has become the catch phrase of her White House campaign, her initial healthcare plan was comparatively light on details. She has said “I’m with Bernie on Medicare for All” when asked about her stance.
‘VERY DILIGENT’
In last week’s presidential debate, Sanders said it would be “appropriate to acknowledge that taxes will go up” if the proposal is enacted, which could require approval from both chambers of the U.S. Congress.Buttigieg on the campaign trail has slammed Warren for not detailing how she would pay for Medicare for all.
Sanders is one reason why Warren has yet to address whether middle-class tax rates would go up. “She’s trying to be respectful of his genuine thought leadership here,” said one progressive activist close to the campaign.
Another is that her campaign has solicited input from experts on a variety of Medicare for All financing options, including at least one that would not necessitate a middle-class tax hike.
Robert Pollin, an economics professor at the University of Massachusetts-Amherst who studied financing options for Sanders’ 2017 Medicare for All bill and has advised both his and Warren’s campaigns, estimated that a single-payer healthcare system would have cost the government $37.8 trillion over 2017-2026. New sources of revenue would be needed to cover about $13.5 trillion of that, he estimated.
Pollin said in an interview that his research shows a 1.8% business tax on gross receipts, a 3.75% federal sales tax on non-essential goods and a 0.38% tax on wealth above $1 million would respectively generate about $600 billion, $200 billion and $200 billion annually. That, along with cost savings associated with a single-payer system, would account for the $13.5 trillion needed.
He said he designed his plan to minimize impact on consumer behavior, keep the burden on employers to cover some healthcare costs via the business tax and that lower-income households would be exempt from the sales-tax on non-essential goods.
A middle-class household with an annual income of $60,000 would pay about $900 a year in sales tax. Depending on current healthcare costs, however, it would save about $2,000 to $8,000 each year, he said.
Pollin said his discussions with Warren’s campaign are ongoing and its questions have been “very diligent.”
“The notion that Elizabeth Warren’s staff or Elizabeth Warren herself has neglected this is very false. They’re trying to be very, very careful,” he said.
https://www.reuters.com/article/us-usa-election-warren-medicare/democratic-2020-hopeful-warren-still-weighing-medicare-for-all-financing-options-idUSKBN1X0278
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