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Sunday, June 10, 2018

AMA to reconsider policy against assisted suicide


American Medical Association delegates meet in Chicago this week to vote on whether the group’s Code of Medical Ethics should allow assisted suicide.
Six states and the District of Columbia have legalized the practice, but it remains divisive. The AMA has had the same guidance for a quarter-century: ‘‘Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.’’
But ethics experts say views are evolving. ‘‘The mere fact that they’re considering it again tells you that it’s a changing climate,’’ said Art Caplan, head of medical ethics at the New York University School of Medicine.
It’s uncertain which way the vote will go, but in an open forum on the AMA’s website, doctors, delegates, and others showed strong support for the status quo.

Polio makes comeback in Venezuela after decades


Polio has been reported in Venezuela, a crisis-wracked country where the disease had been eradicated decades ago, the Pan-American Health Organization reports.
The organization said the child had no history of vaccination and lives in an under-immunized extremely impoverished Delta Amacuro state.
Polio, or poliomyelitis, is a crippling childhood disease caused by the poliovirus, and preventable through immunization.
Doctor Jose Felix Oletta, a former Minister of Health, told AFP that the last case of acute poliomyelitis in Venezuela was reported in 1989.
“The virus especially affects people in conditions of malnutrition and unvaccinated, as this case,” Oletta added.
Oletta slammed health authorities in President Nicolas Maduro’s government for taking more than a month to notify the PAHO that it had identified the virus. International  regulations require it to do so within 24 hours.
Venezuela, devastated by economic and political crises, also accounted for 85 percent of  of measles reported across Latin America and the Caribbean over the past year, the PAHO said.
Of the 11 countries that reported cases, Venezuela had the overwhelming majority of cases, but also 35 deaths since mid-2017, the international organization said.
More specifically, “there were eleven countries that reported 1,685 confirmed measles cases across the region,” of which 1,427 were in Venezuela, a PAHO report released Saturday found.
The  is on the rise in the South American nation led by leftist Maduro; the trend has continued this year where cases have been reported in 17 out of 23 states, and in the capital.
In neighboring countries, where Venezuelans have migrated due to grim economic conditions, many of the reported cases have been among Venezuelan immigrants, the report said.
Venezuela says it does not have 85 percent of the basic medical supplies it needs even including vaccines. Maduro’s government blames US sanctions for the woes.
The government on April 6 launched a new vaccine campaign against 14 diseases including measles and TB.

Development of vaccines from AIDS to Zika, on novel ‘plug & play’ viral platform


Researchers from GeoVax have developed a flexible “Plug and Play” technology platform that delivers single-dose vaccines that fully protect against emerging infectious diseases such as Zika, Lassa fever, and Ebola. The research will be presented at ASM Microbe, the annual meeting of the American Society for Microbiology, held from June 7th to June 11th in Atlanta, Georgia.
“Unlike other vaccine technologies currently available, which sacrifice confidence in success for speed or vice-versa, the GeoVax technology offers a true “Plug and Play”  approach that is well suited for use against a wide range of biological threats and amenable to rapid, large-scale production,” said Rahul Basu, scientist at GeoVax and lead author on the study.
Vaccines produced in this platform are safe, highly immunogenic, and effective against a wide range of indications. The vaccines are suitable for repeated use, stable at refrigerator temperatures or lyophilized for non-cold chain needle-free application, and amenable to rapid and affordable scale-up for use in both epidemic response and routine vaccination.
“A significant unmet medical need exists for vaccine platform technologies to respond rapidly and effectively against biological threats,” said Mr. Basu, “Preferably, such platforms should deliver vaccines that are safe and confer full protection after a single dose.”
In proof-of-concept studies, the researchers tested three independent vaccines against three different families of viruses. Each vaccine demonstrated full protection after a single dose, using various lethal challenge models. For the Zika vaccine, a single inoculation of MVA-Zika vaccine in normal (immunocompetent) mice provided 100% protection against a lethal challenge dose of a neurovirulent ZIKV delivered directly into the brain. A single inoculation of MVA-VLP-Ebola vaccine candidate provided full protection in a rhesus monkey lethal challenge model. A single inoculation of MVA-VLP-LASV protected mice against a lethal challenge delivered directly into the brain.
“To demonstrate a broad utility of the platform, we developed prophylactic and therapeutic vaccines for other infectious diseases as well as cancer,” said Mr. Basu. These included prophylactic and therapeutic vaccines for HIV (already in advanced clinical trials), preventive vaccines for Marburg, Sudan and Malaria, all with major epidemic potential with high human lethality, as well as therapeutic vaccines for chronic hepatitis B infections and tumor-associated antigen (TAA)-based-cancer vaccines.
These studies on single-dose vaccines for emerging  were supported with funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and performed at laboratories of the Centers for Disease Control, (CDC) in Fort Collins, CO, Institute of Human Virology, University of MD and NIH’s Rocky Mountain Laboratories have demonstrated the broad utility of the platform. These are described in a Late-breaking presentation at the ASM Microbe 2018 meeting in Atlanta.

New and Improved Way to Screen for Dementia in Primary Care


Hello. I’m Dr Arefa Cassoobhoy, a practicing internist, Medscape advisor, and senior medical director for WebMD. Welcome to Morning Report, our 1-minute news story for primary care.
Screening for dementia is more common in the primary care of older adults. Many clinicians use the Mini Mental State Exam (MMSE) for this purpose, but its sensitivity for early symptoms of cognitive impairment is low.
A recent analysis looked at improving dementia prediction. About 2700 adults, aged 70-78 years, were given the MMSE plus another screening tool called the Visual Association Test (VAT). It’s a 3-minute test that uses pictorial cue cards to evaluate associative memory.
Over the next 6-8 years they analyzed the predictive value of both of these tests to diagnose dementia. Patients with a decline in their MMSE and an imperfect VAT score were more likely to be diagnosed with dementia. Those with a slight decline on the MMSE and a perfect VAT score were not at increased risk compared with the entire cohort.
This is a simple test to consider adding to help distinguish older adults who need further cognitive testing from those in whom watchful waiting is justified.

Aetna leans on analytics, state health units to curb antibiotic overprescribing


Nearly a year after launching an initiative with the Centers for Disease Control and Prevention (CDC), Aetna has sent nearly 1,500 letters to antibiotic “superprescribers” across 43 states as part of an effort to reduce overprescribing.
The insurer has also partnered with health departments in six states, using co-branded letters signed by state officials to strengthen the messaging. Aetna used its existing partnership with the CDC to connect with states where it had a high membership and the health department was interested in controlling antibiotic prescribing.
“A co-branded letter from the Department of Health sends a stronger message,” Dan Knecht, M.D., Aetna’s head of clinical strategy, told FierceHealthcare. “It’s from a local health official, not just your insurance carrier. I think that also shows this is an issue that the state, as well as the CDC, take seriously.”
The six states were California, Florida, Maryland, New Jersey, Texas and Virginia. In Texas, the state’s health commissioner included an accompanying letter warning about the threats of antibiotic resistance.

Aetna launched the initiative with the CDC last year, focusing on antibiotic prescribing for acute bronchitis in adults. According to the CDC, the viral infection should not be treated with antibiotics, but Knecht says doctors continue to prescribe them unnecessarily.
A study published in the medical journal Antibiotics in December found that 62% of adults with uncomplicated acute bronchitis were prescribed antibiotics at family medical clinics between 2011 and 2016, building on previous literature that showed similar statistics.
Using data analytics, Aetna isolated physicians in its network that inappropriately prescribed antibiotics for bronchitis at least 50% of the time to at least five members. Across 43 states, Aetna sent letters to 1,445 so-called “superprescribers.”
Of those physicians, 432 were repeat superprescribers, meaning they received a letter last year but continued to prescribe high rates of antibiotics. Those physicians received a second certified letter.

Aetna also sent 175 letters to antibiotic stewardship “champions,” providers that avoided inappropriate antibiotic prescribing 100% of the time for at least three members with bronchitis. Twenty of those physicians were repeat champions.
Recent research shows that when it comes to reducing antibiotic prescribing, physicians respond to peer comparison better than other EHR-based behavioral interventions.
“[Doctors are a] competitive group of people, and if we know we’re falling outside the norm or not practicing evidence-based medicine as much as we should, that serves as an incentive to potentially change practice behavior,” Knecht said.
He added that the insurer’s access to claims and pharmaceutical data, combined with advanced analytics, play a key role in “unlocking some powerful insights.”
Although antibiotics are “almost pennies,” according to Knecht, research shows the treatment costs associated with resistance exceeds $2.2 billion annually, twice as much as estimates from 2002.
Aetna is getting Healthcare Effectiveness Data and Information Set (HEDIS) results in the coming months, which will help the insurer understand the tangible impact of its initiative. From there, Aetna plans to refine its efforts and coordinate with additional state health departments.
“We’ll see if these providers change habits,” Knecht said. “If they don’t, we need to think of other ways to use both carrots and sticks to change behaviors.”

Biotech week ahead, June 11


The ASCO conference closed Tuesday, although presentations at the conference triggered some huge stocks movesNektar Therapeutics NKTR 2.21% slumped about 42 percent, while Deciphera Pharmaceuticals Inc DCPH 2.12% has rallied about 60 percent since June 1.
Here’s a look at the upcoming week’s catalytic events.

Conferences

  • 41st European Congress of Cytology – June 10-13, in Madrid, Spain
  • 31st International Conference On Antiviral Research, or ICAR – June 11-15, in Porto, Portugal
  • Goldman Sachs 39th Annual Global Healthcare Conference – June 12-14, in Rancho Palos Verdes, California
  • Annual European Congress of Rheumatology, 2018 – June 13-16, in Amsterdam, Netherlands
  • UK Oncology Forum – June 14-15, in Liverpool, U.K.
  • 23rd Congress of European Hematology Association, or EHA, – June 14-17, in Stockholm, Sweden
  • 52nd European Human Genetics Conference in conjunction with the European Meeting on Psychological Aspects of Genetics – June 16-19, in Milan, Italy

Clinical Trial Presentations

Chimerix Inc CMRX 3.9% is due to present Phase 1 data on its norovirus treatment candidate CMX521 at the ICAR between June 11-15. The company recently received orphan drug designation to its smallpox treatment candidate brincidofovir.
Beigene Ltd (ADR) BGNE 1.56% will present Phase 1/2 data for its Zanubrutinib, its treatment candidate for Waldenstrom’s macroglobulinemia, at the EHA on Friday.
AbbVie Inc ABBV 1.12% and Roche Holdings AG Basel ADR Common Stock RHHBY 0.81% will present Phase 3 data for Venclexta, their relapsed or refractory chronic lymphocytic leukemia, or CLL, treatment candidate, at the EHA on Saturday.
bluebird bio Inc BLUE 0.27% is due to present Phase 3 data on LentiGlobin, code named HGB-207, from a study called Northstar-2, which evaluated the pipeline candidate for non-beta0/beta0 transfusion-dependent thalassemia, at the EHA on Saturday.

IPOs

Verrica Pharmaceuticals, a clinical-stage dermatology company, is scheduled to IPO, offering 5 million shares at an estimated price range of $14 to $16. The company seeks to list its shares on the Nasdaq under the ticker symbol VRCA.

KKR nears agreement to acquire Envision for about $5.5 billion


Private equity firm KKR & Co is nearing an agreement to acquire U.S. physician services provider Envision Healthcare Corp for $46 a share, or about $5.5 billion, a person familiar with the deal told Reuters on Sunday.

A deal could be announced as soon as Monday, the source said.
A KKR spokeswoman declined to comment. Envision did not respond to a request for comment outside regular business hours.
The agreement will come less than two weeks after KKR said it will buy U.S. business software company BMC Software in a deal which sources valued at $8.5 billion, including debt, making it the buyout firm’s largest acquisition since the 2008 financial crisis.
Reuters reported last month that KKR and U.S. hospital operator HCA Healthcare Inc had joined forces to make an offer for Envision, with the move aimed at giving HCA and KKR an edge over buyout firms, which were also pursuing Envision.
Other private equity firms competing for Envision included a consortium of Carlyle Group LP and TPG Global, sources told Reuters in May.
Envision said in 2017 that it was reviewing a range of strategic alternatives after reporting disappointing third-quarter earnings, which were attributed partly to the impacts of hurricanes Harvey and Irma, along with a slowdown in the growth of patient demand.
The Wall Street Journal had earlier reported that KKR is nearing a deal to buy Envision.
KKR had agreed last month to acquire BMC from private equity companies Bain Capital and Golden Gate Capital, which bought BMC for $6.9 billion in 2013.
KKR had a successful year for fundraising in 2017, with the private equity firm’s fund closings including a $13.9 billion North America private equity fund and a $1.45 billion healthcare fund.