Nearly half of the estimated 56 million abortions performed worldwide every year are unsafe and women in poor countries face even higher risks due to U.S. funding cuts to family planning programs abroad, health experts said on Thursday.
Reuters Health Information
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Kamis, 28 September 2017
WHO Reports 25 Million Unsafe Abortions a Year; Expert Sees Higher Risk From U.S. Cutbacks
WHO Reports 25 Million Unsafe Abortions a Year; Expert Sees Higher Risk From U.S. Cutbacks
Flu Vaccination Rates Among Healthcare Workers Have Plateaued
Flu Vaccination Rates Among Healthcare Workers Have Plateaued
In addition, vaccination rates in the general US population were disappointingly low last year; they were highest in children aged 6 to 23 months, the CDC said.
Medscape Medical News
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Vaccine Order Boosts Bavarian Nordic After Cancer Drug Flop
Vaccine Order Boosts Bavarian Nordic After Cancer Drug Flop
COPENHAGEN (Reuters) – Biotech group Bavarian Nordic said it expected to win more contracts in the United States for its smallpox vaccine after securing an order from the U.S. government stockpile.
The Danish company said late on Wednesday it had won the order for its freeze-dried smallpox vaccine worth potentially $539 million from BARDA, a division of the U.S. Department of Health and Human Services.
The deal was a boost for the Danish company, coming just weeks after its prostate cancer drug candidate suffered a major setback.
“This should calm the market further with regards to the failed Prostvac phase III-study,” Sydbank analyst Soren Lontoft Hansen, said referring to the cancer drug Prostvac disappointment. He has a ‘buy’ rating on the stock.
Bavarian’s shares rose as much as 5% on Thursday, partly due to a higher-than-expected vaccine dose price. They are still around 35 below their peak level before the news of the failed cancer drug study.
“We are expecting that they (the U.S. Biomedical Advanced Research and Development Authority (BARDA)) have a desire to expand the emergency stock for the smallpox vaccine and therefore we also expect to see more contracts in the future,” Chief Financial Officer Ole Larsen told Reuters.
This is Bavarian’s third such award to manufacture vaccine in bulk and the two prior orders from BARDA totalled $233 million, which the firm has already received.
The new contract will cover around 13 million doses at a price of around $48 per dose, Larsen said, underlining that uncertainties around price and volume still remained.
The price is significantly higher than the $35 expected by some analysts.
Bavarian Nordic will also invest in the construction of a manufacturing line at its facility in Denmark with a possible co-investment from BARDA to secure future production capacity.
The order would be for a new freeze-dried formulation of the vaccine with a shelf life of more than five years, which will replace the liquid-frozen formulation with a three-year durability of Imvamune currently stockpiled.
The U.S. government has a long-term strategy to provide sufficient non-replicating smallpox vaccine to protect 66 million people, representing 132 million doses of Imvamune, Bavarian said on its web page.
Trump Vows Another Healthcare Vote Next Year, Eyes Executive Order
Trump Vows Another Healthcare Vote Next Year, Eyes Executive Order
WASHINGTON (Reuters) – President Donald Trump, faced with the latest Republican failure to undo Obamacare, pledged on Wednesday to tackle it again next year, suggesting without evidence that he had the votes to pass reform and promising to work with Democrats in the meantime.
Trump told reporters at the White House that he also was working on an executive order, possibly to be signed next week, that would allow individuals to buy health insurance across state lines.
Senate Republicans abandoned their latest effort to repeal former President Barack Obama’s Affordable Care Act on Tuesday after failing to secure sufficient support from fellow Republicans.
Trump said there would be another vote on healthcare in the first few months of 2018 and he would work with Democrats to make the effort more bipartisan. Democrats strongly oppose repealing and replacing Obama’s signature domestic policy achievement.
“I am . . . going to meet with Democrats, and I will see if I can get a healthcare plan that’s even better,” Trump said. “So I will negotiate with Democrats, but from the Republican standpoint, we have the votes. We’ll vote in January, February or March.”
Trump did not explain the discrepancy between his conviction that the votes were there and the fact that not enough Republican senators supported the latest bill, forcing Republican leaders to scrap plans to hold a vote.
Republicans control the Senate by a 52-48 margin.
The bill’s sponsors vowed to try again but face steeper odds after Saturday, when special rules expire that allow them to pass healthcare legislation without Democratic support.
Trump told reporters that one of the votes they needed was of a senator who was in the hospital, Senator Thad Cochran of Mississippi. Cochran’s office said the senator was not in the hospital but was recovering after being treated for a “urological issue.”
Republican Senators John McCain, Susan Collins and Rand Paul opposed the bill.
ACROSS STATE LINES
Paul has encouraged Trump to legalize nationwide health associations, which he says would allow people to get group health insurance across state lines. Trump said he was working on a measure to do that.
“I am considering an executive order on associations and that will take care of a tremendous number of people with regard to healthcare and I’ll probably be signing a very major executive order where people can go out, cross state lines, do lots of things and buy their own healthcare,” Trump said.
He said the order was in the process of being finished. The effort appeared to be a move to woo Paul. Trump said later he thought the senator from Kentucky would come around on the broader push for legislation.
“I think Rand will be there for us,” Trump told reporters.
UCLA Professor Mark Peterson expressed doubt that insurance prices would be reduced by selling across state lines because insurers would still be subject to ACA regulations requiring coverage of hospital care, prescription drugs, pregnancy and childbirth needs and mental health services.
“What drives cost of care is the cost of medical care. If I’m in California, which is an expensive medical care state and I buy my insurance from Delaware, which is not, I’m still going to doctors and hospitals that are very expensive and the insurance plan is either going to cover that or not,” he said.
Congressional leaders said on Tuesday they were moving on to tax reform legislation. But the Senate’s No. 2 Republican, John Cornyn, said on Wednesday that lawmakers would continue to work on healthcare. He said the authors of the most recent Obamacare repeal bill, Senators Lindsey Graham and Bill Cassidy, hoped to increase support for their proposal.
Republican Senator Lamar Alexander and Democrat Patty Murray resumed their bipartisan talks on Wednesday seeking a deal to help stabilize health insurance markets, a Murray spokeswoman said. She had no details. Alexander chairs the Senate health committee and Murray is the panel’s top Democrat.
FDA Warns of Uptick in Endoleaks With Endovascular Grafts
FDA Warns of Uptick in Endoleaks With Endovascular Grafts
SILVER SPRING, MD — There appears to have been an increase in type IIIa and IIIb endoleaks with endovascular graft systems used for endovascular aneurysm repair (EVAR), the US Food and Drug Administration (FDA) warned today in a safety communication[1].
In a letter to vascular and cardiothoracic surgeons, radiologists, and cardiologists[2], the FDA says: “We are bringing this potential complication to your attention to remind and encourage you to report type IIIa and IIIb endoleak events to the manufacturer and the FDA. This may include reporting individual events as well as rates you may have experienced in your practice.”
EVAR treats abdominal aortic aneurysms (AAA) and aortoiliac aneurysms. The procedure is intended to exclude the AAA sac from the arterial circulation and prevent AAA rupture. In the presence of a type III endoleak, the AAA is not excluded from flow and systemic arterial pressurization of the aneurysm sac, increasing the risk of rupture, the FDA notes.
According to the agency, recent information from several sources, including the FDA’s medical-device reporting database and annual clinical updates to physicians by the manufacturers, suggests an increase in the occurrence of type III endoleaks. “This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs,” the FDA says.
The FDA is working with manufacturers of endovascular graft systems to better understand problem, including the prevalence of type III endoleaks, contributing factors, and the risks and benefits of secondary interventions to address these endoleaks.
The FDA considers a type III endoleak a device-related event requiring additional interventions such as relining, insertion of additional endograft components, or open surgical repair. Secondary interventions to address endoleaks carry added risks for patients, the FDA says. Predictors of type III endoleak may include treatment with early-generation graft materials, the presence of calcified plaque, and inadequate overlap between components.
The FDA is recommending that health care providers:
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Continue lifelong surveillance of patients treated with endovascular grafts.
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Consider type III endoleaks in the differential diagnosis of patients with symptoms of potential aneurysm expansion or rupture.
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Discuss with patients all available treatment options to address type III endoleaks, including the risks and benefits of each, before deciding the best treatment approach.
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Using MedWatch, report early or late device-related adverse events, including type III endoleaks associated with the use of endovascular graft systems in EVAR, or device-related adverse events that occur as a result of a secondary intervention to treat type III endoleaks.
For more from theheart.org Medscape Cardiology, follow us on Twitter and Facebook.
Cardiologist Care in Hospital Yields Better HFpEF Outcomes
Cardiologist Care in Hospital Yields Better HFpEF Outcomes
GRAPEVINE, TX — A third of patients admitted with acute heart failure with preserved ejection fraction (HFpEF) were assigned to care by generalist physicians, and a cardiology consult was sought in only a few of those cases, in a retrospective analysis covering a recent 4 months at a major academic tertiary-care center[1].
Moreover, HFpEF patients admitted to a generalist team were more likely to be rehospitalized within a week of discharge, compared with those assigned to the cardiology service.
“Patients cared for by cardiologists received much higher doses of diuretic during their time in the hospital and at time of discharge,” Dr Caitlin S Drescher (Brigham and Women’s Hospital, Boston, MA) told theheart.org | Medscape Cardiology.
“So I think cardiologists are little bit more aggressive with their diuretic strategy, and that may contribute to being able to keep patients out of the hospital longer.”
On the other hand, those who went to generalists were more likely to have comorbidities that complicated their presentation, such as diabetes or chronic obstructive pulmonary disease (COPD), that might have swayed which clinician team managed their care.
Baseline Features of Patients Hospitalized With HFpEF, by Admitting Service
| End points | General medicine, n=50 (%) | Cardiology/heart failure, n=101 (%) | P |
|---|---|---|---|
| White | 46 | 72.3 | 0.002 |
| Atrial fibrillation | 44 | 67.3 | 0.006 |
| Valve disease | 26 | 47.5 | 0.011 |
| Diabetes | 60 | 43.6 | 0.057 |
| COPD | 48 | 29.7 | 0.027 |
COPD=chronic obstructive pulmonary disease
“If it’s more equivocal, they’re more likely to go to a generalist,” she said. That’s possible even when it’s clearly a heart-failure exacerbation but the patient is “medically complicated,” said Drescher, who presented the analysis at the Heart Failure Society of America 2017 Scientific Meeting.
For example, “if they also have difficult-to-manage diabetes or recently had pneumonia, that may also tip the scales to send a patient to a generalist service instead of a cardiologist.”
Similarly in the study, patients who went to the cardiology service were more likely to have atrial fibrillation or valve disease that may have boosted their chances of going to the cardiology service, she said.
The findings are consistent with published data going back more than a decade, in broader populations with acute heart failure, including analyses from Canada and the US[2]. The latter saw significantly fewer 6-month rehospitalizations with cardiologist hospital care, but there wasn’t a similar effect on 6-month mortality.
Based on national statistics, “it appears that patients with preserved-EF heart failure are very often managed by noncardiologists. This speaks in some ways to changing management in hospitals, where hospitalist-driven evaluation and management has grown,” Dr James L Januzzi Jr (Massachusetts General Hospital, Boston) said in an interview.
“Cardiology, at many if not most medical centers, simply doesn’t have the capacity to manage every single patient in the house with heart failure.”
But he agreed that “patients managed by cardiologists are going to be more likely assessed and managed in a more aggressive fashion.” In the analysis, that’s apparent from their greater use of diuretics “as well as use of cardiac catheterization, presumably right-heart catheterization, during hospitalization.” Januzzi isn’t connected with the current analysis.
“Perhaps the most important result of this study is the fact that patients managed by cardiology were more likely to demonstrate continuity of care,” he said, pointing the much greater likelihood that such patients would have a cardiology appointment within 7 days of discharge. “This more likely than not explains the reduced short-term rehospitalization and mortality.”
Drescher agreed. “Having that kind of short-term follow-up outside of the hospital to make sure everything is going kind of as planned and whether any further adjustments need to be made at that time—that someone is seeing the patient and making those adjustments—I think that probably plays quite a large role in keeping patients out of the hospital.”
In-Hospital and Discharge Management in Patients Hospitalized with HFpEF, by Admitting Service
| End points | General medicine, n=50 (%) | Cardiology/heart failure, n=101 (%) | P |
|---|---|---|---|
| Cardiac catheterization during stay (%) | 4 | 18.8 | 0.013 |
| Discharge diuretic dose (mg furosemide equivalent) | 152 | 267.1 | 0.017 |
| Outpatient cardiologist appointed (%) | 49 | 86.1 | <0.001 |
| Cardiology appointment within 7 days of discharge (%) | 4 | 18.8 | 0.013 |
| Cardiology appointment within 14 days of discharge (%) | 12 | 34.7 | 0.003 |
More broadly, the findings “indicate how a cross-disciplinary collaboration between cardiologists and noncardiologists can optimally manage these patients and is so necessary,” according to Januzzi.
“It might very well have the general medicine person as the quarterback of the team but might involve the consultative input of a specialist for the various medical conditions these patients seem to have,” he said. “Knowing when and why a cardiologist should get involved is definitely something that we can all work on together.”
Of 294 HF admissions at Drescher’s center in the analysis, 145 had reduced-EF heart failure (HFrEF). Of those, 86.2% went to cardiology team and 13.8% to generalist team. Of the latter group, 40% had a cardiology consult.
In contrast, 33.1% of those with HFpEF, meaning they had an ejection fraction >40%, were assigned to a generalist service. Only 12% had a cardiology consult, and only half were followed by a cardiologist as outpatients.
Outcomes of Patients Hospitalized with HFpEF, by Admitting Service
| Postdischarge HF readmission or death from any cause | General medicine, n=50 (%) | Cardiology/heart failure, n=101 (%) | P |
|---|---|---|---|
| At 7 d* | 16 | 5.0 | 0.023 |
| At 30 d | 32 | 23.8 | 0.280 |
*No deaths
Both Drescher and Januzzi wondered, given that the current data are from a nationally recognized academic referral center, what the picture is like nationally, especially at smaller hospitals.
“It’s reasonable to expect that these findings would be different at a nonacademic medical center, although it remains to be seen exactly how that would be,” Januzzi said.
Her center’s 30-day readmission numbers are “near the national average. We are a tertiary center, so we tend to have sicker patients and more complex, more serious comorbidities among our heart-failure population,” Drescher said.
On the other hand, “We are lucky to have a lot of expertise in the physicians at the Brigham and a lot of resources at our disposal. So I’m not sure how different these data would be at a community hospital, at a less resource-rich hospital system.”
That’s one of the next steps for this research, she said.
Drescher had no relevant financial relationships. Januzzi said he has no relevant financial relationships.
Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
Early Remission Rare With Standard Treatment Of Pediatric UC
Early Remission Rare With Standard Treatment Of Pediatric UC
NEW YORK (Reuters Health) – Most children and adolescents starting treatment for ulcerative colitis (UC) with standardized therapy will not achieve steroid-free remission at 12 weeks, according to findings published in Lancet Gastroenterology and Hepatology.
“Our data reveal a sobering early course for children with new-onset ulcerative colitis,” Dr. Jeffrey Hyams of Connecticut Children’s Medical Center in Hartford and colleagues write in their September 20 online report. Given the findings, they suggest, additional interventions may be needed to improve early outcomes in pediatric UC patients, especially those who are severely ill and require intravenous corticosteroids as first-line treatment.
Current initial treatment for children with UC is based on evidence from clinical trials in adults, Dr Hyams and his team note. They launched the PROTECT study in 2012 to study how 428 children (mean age, 13) with newly diagnosed UC responded to standardized treatment with mesalazine (136 patients), oral corticosteroids (144), or intravenous corticosteroids (148).
At 12 weeks, 48% of patients on mesalazine, 33% on oral corticosteroids, and 21% on IV corticosteroids had achieved corticosteroid-free remission. Seven percent of the mesalazine group, 15% of the oral corticosteroid group, and 36% of the IV corticosteroid group required treatment escalation. Eight patients initially receiving IV corticosteroids underwent colectomy.
Factors predicting remission at 12 weeks included a Pediatric Ulcerative Colitis Activity Index (PUCAI) score below 35 (odds ratio 2.44), higher baseline albumin per 1-g/dL increase in children younger than 12 (OR, 4.05), and remission at 4 weeks (OR, 6.26).
Patients who started on IV corticosteroids were significantly more likely to require treatment escalation by week 12 if they had a baseline total Mayo score of 11 or higher (OR, 2.59), a rectal biopsy eosinophil count of 32 cells per high-power field or less (OR, 4.55), rectal biopsy surface villiform changes (OR, 3.05), or were not in remission at week 4 (OR, 30.28).
“Our results show that clinical activity indices, including PUCAI and Mayo score, can be combined with serum albumin and specific histological features of rectal biopsies to judge the likelihood of success for first-line therapies, and that week 4 remission is a crucial juncture to guide additional therapies,” Dr. Hyams and colleagues write. “These data suggest that additional therapeutic interventions could be warranted to improve early outcomes, especially in children presenting with severe disease and requiring treatment with intravenous corticosteroids.”
The findings suggest that using a “systematic approach” will help clinicians make decisions on early treatment in pediatric UC patients, Dr. James Ashton of Southampton Children’s Hospital and Dr. R. Mark Beattie of the University of Southhampton, UK, write in a comment accompanying the study. In adults, they add, treatment has shifted toward starting patients on anti-TNF therapy or immunomodulating drugs, but pediatric practitioners have raised concerns about the toxicity of these treatments.
“While current evidence is not yet adequate to provide a firm answer to whether we should be adopting a ubiquitous top-down approach in paediatric ulcerative colitis, this study does offer intriguing data indicating that there is significant room for improvement in early remission rates, and that earlier treatment escalation, especially in moderate to severe disease, should be considered,” they conclude.
Dr. Hyams was not available for an interview by press time.
SOURCES: http://bit.ly/2wkJ38x and http://bit.ly/2fQYxLb
Lancet Gastroenterol Hepatol 2017.
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