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Proclivity ID
18813001
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Specialty Focus
Psoriatic Arthritis
Spondyloarthropathies
Rheumatoid Arthritis
Osteoarthritis
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
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Rheumatology News
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The leading independent newspaper covering rheumatology news and commentary.

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If you give a mouse a genetically engineered bitcoin wallet

Article Type
Changed
Thu, 02/03/2022 - 09:25

 

The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

 

 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

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The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

 

 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

 

The world’s most valuable mouse

You’ve heard of Mighty Mouse. Now say hello to the world’s newest mouse superhero, Crypto-Mouse! After being bitten by a radioactive cryptocurrency investor, Crypto-Mouse can tap directly into the power of the blockchain itself, allowing it to perform incredible, death-defying feats of strength!

We’re going to stop right there before Crypto-Mouse gains entry into the Marvel cinematic universe. Let’s rewind to the beginning, because that’s precisely where this crazy scheme is at. In late January, a new decentralized autonomous organization, BitMouseDAO, launched to enormous … -ly little fanfare, according to Vice. Two investors as of Jan. 31. But what they lack in money they make up for in sheer ambition.

Clker-Free-Vector-Images/Pixabay

BitMouseDAO’s $100 million dollar idea is to genetically engineer mice to carry bitcoin, the first cryptocurrency and one of the most valuable. This isn’t as crazy an idea as it sounds since DNA can be modified to store information, potentially even bitcoin information. Their plan is to create a private bitcoin wallet, which will be stored in the mouse DNA, and purchase online bitcoin to store in this wallet.

BitMouseDAO, being a “collection of artists,” plans to partner with a lab to translate its private key into a specific DNA sequence to be encoded into the mice during fertilization; or, if that doesn’t work, inject them with a harmless virus that carries the key.

Since these are artists, their ultimate plan is to use their bitcoin mice to make NFTs (scratch that off your cryptocurrency bingo card) and auction them off to people. Or, as Vice put it, BitMouseDAO essentially plans to send preserved dead mice to people. Artistic dead mice! Artistic dead mice worth millions! Maybe. Even BitMouseDAO admits bitcoin could be worthless by the time the project gets off the ground.

If this all sounds completely insane, that’s because it is. But it also sounds crazy enough to work. Now, if you’ll excuse us, we’re off to write a screenplay about a scrappy group of high-tech thieves who steal a group of genetically altered bitcoin mice to sell for millions, only to keep them as their adorable pets. Trust us Hollywood, it’ll make millions!
 

Alcoholic monkeys vs. the future of feces

Which is more important, the journey or the destination? Science is all about the destination, yes? Solving the problem, saving a life, expanding horizons. That’s science. Or is it? The scientific method is a process, so does that make it a journey?

Amandad/Pixabay

For us, today’s journey begins at the University of Iowa, where investigators are trying to reduce alcohol consumption. A worthy goal, and they seem to have made some progress by targeting a liver hormone called fibroblast growth factor 21 (FGF21). But we’re more interested in the process right now, so bring on the alcoholic monkeys. And no, that’s not a death metal/reggae fusion band. Should be, though.

“The vervet monkey population is [composed] of alcohol avoiders, moderate alcohol drinkers, and a group of heavy drinkers,” Matthew Potthoff, PhD, and associates wrote in Cell Metabolism. When this particular bunch of heavy-drinking vervets were given FGF21, they consumed 50% less alcohol than did vehicle-treated controls, so mission accomplished.

Maybe it could be a breakfast cereal. Who wouldn’t enjoy a bowl of alcoholic monkeys in the morning?

And after breakfast, you might be ready for a digitized bowel movement, courtesy of researchers at University of California, San Diego. They’re studying ulcerative colitis (UC) by examining the gut microbiome, and their “most useful biological sample is patient stool,” according to a written statement from the university.

“Once we had all the technology to digitize the stool, the question was, is this going to tell us what’s happening in these patients? The answer turned out to be yes,” co-senior author Rob Knight, PhD, said in the statement. “Digitizing fecal material is the future.” The road to UC treatment, in other words, is paved with digital stool.

About 40% of the UC patients had elevated protease levels, and their high-protease feces were then transplanted into germ-free mice, which subsequently developed colitis and were successfully treated with protease inhibitors. And that is our final destination.

As our revered founder and mentor, Josephine Lotmevich, used to say, an alcoholic monkey in the hand is worth a number 2 in the bush.
 

 

 

Raise a glass to delinquency

You wouldn’t think that a glass of water could lead to a life of crime, but a recent study suggests just that.

PxHere

Children exposed to lead in their drinking water during their early years had a 21% higher risk of delinquency after the age of 14 years and a 38% higher risk of having a record for a serious complaint, Jackie MacDonald Gibson and associates said in a statement on Eurekalert.

Data for the study came from Wake County, N.C., which includes rural areas, wealthy exurban developments, and predominantly Black communities. The investigators compared the blood lead levels for children tested between 1998 and 2011 with juvenile delinquency reports of the same children from the N.C. Department of Public Safety.

The main culprit, they found, was well water. Blood lead levels were 11% higher in the children whose water came from private wells, compared with children using community water. About 13% of U.S. households rely on private wells, which are not regulated under the Safe Drinking Water Act, for their water supply.

The researchers said there is an urgent need for better drinking-water solutions in communities that rely on well water, whether it be through subsidized home filtration or infrastructure redevelopment.

An earlier study had estimated that preventing just one child from entering the adult criminal justice system would save $1.3 to $1.5 million in 1997 dollars. That’s about $2.2 to $2.5 million dollars today!

If you do the math, it’s not hard to see what’s cheaper (and healthier) in the long run.
 

A ‘dirty’ scam

Another one? This is just getting sad. You’ve probably heard of muds and clays being good for the skin and maybe you’ve gone to a spa and sat in a mud bath, but would you believe it if someone told you that mud can cure all your ailments? No? Neither would we. Senatorial candidate Beto O’Rourke was definitely someone who brought this strange treatment to light, but it seems like this is something that has been going on for years, even before the pandemic.

Nandan/Pixahive

A company called Black Oxygen Organics (BOO) was selling “magic dirt” for $110 per 4-ounce package. It claimed the dirt was high in fulvic acid and humic acid, which are good for many things. They were, however, literally getting this mud from bogs with landfills nearby, Mel magazine reported.

That doesn’t sound appealing at all, but wait, there’s more. People were eating, drinking, bathing, and feeding their families this sludge in hopes that they would be cured of their ailments. A lot of people jumped aboard the magic dirt train when the pandemic arose, but it quickly became clear that this mud was not as helpful as BOO claimed it to be.

“We began to receive inquiries and calls on our website with people having problems and issues. Ultimately, we sent the products out for independent testing, and then when that came back and showed that there were toxic heavy metals [lead, arsenic, and cadmium among them] at an unsafe level, that’s when we knew we had to act,” Atlanta-based attorney Matt Wetherington, who filed a federal lawsuit against BOO, told Mel.

After a very complicated series of events involving an expose by NBC, product recalls, extortion claims, and grassroots activism, BOO was shut down by both the Canadian and U.S. governments.

As always, please listen only to health care professionals when you wish to use natural remedies for illnesses and ailments.

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10 things not to do in a medical board hearing

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Fri, 02/04/2022 - 07:57

A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

 

 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

 

 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

A version of this article first appeared on Medscape.com.

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A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

 

 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

 

 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

A version of this article first appeared on Medscape.com.

A Florida doctor told his patient her test result would be available in 3-4 days. When the patient didn’t hear back, she called the practice several times, but she didn’t receive a return call. So she filed a complaint against the doctor with the medical board.

When the board investigator interviewed the doctor, the physician said he wasn’t aware the patient had called. But his staff said otherwise. Because the doctor had not been truthful, the board sent him a letter of guidance and required him to attend a training program in ethics.

Miami attorney William J. Spratt Jr., who supplied this anecdote about a former client, said that most complaints are dismissed with no action taken, but some complaints don’t go away because doctors mishandle them.

The following are some common mistakes that physicians make when dealing with a board complaint.
 

1. Not responding to the complaint

The complaint you get from the board – which often comes with a subpoena and a response deadline – usually asks for medical records pertinent to the case.

You can’t disregard the board’s letter, said Doug Brocker, an attorney handling board actions in Raleigh, N.C. “It’s amazing to me that some people just ignore a board complaint. Sometimes it’s because the doctor is just burnt out, which may have gotten the doctor into trouble in the first place.”

If you do not respond to a subpoena, “the board can file a court order holding you in contempt and start taking action on your license,” said Jeff Segal, MD, a neurosurgeon and attorney in Greensboro, N.C. Dr. Segal is CEO of Medical Justice Services, which protects physicians’ reputations associated with malpractice suits and board actions. “Not responding is not much different from agreeing to all of the charges.”
 

2. Not recognizing the seriousness of the complaint

“The biggest mistake is not taking a complaint seriously,” said Linda Stimmel, an attorney at Wilson Elser in Dallas. “Physicians who get a complaint often fire off a brief response stating that the complaint has no merit, without offering any evidence.”

According to Ms. Stimmel, “it’s really important to back up your assertions, such as using excerpts from the medical record, citations of peer-reviewed articles, or a letter of support from a colleague.”

“Weigh your answers carefully, because lack of accuracy will complicate your case,” Mr. Brocker said. “Consult the medical record rather than rely on your memory.”

“Present your version of events, in your own words, because that’s almost always better than the board’s version,” said Dr. Segal.

Even if there was a bad clinical outcome, Dr. Segal said you might point out that the patient was at high risk, or you could show that your clinical outcomes are better than the national average.
 

3. Thinking the board is on your side

You may be lulled into a false sense of security because the physicians on the medical board are your peers, but they can be as tough as any medical malpractice judge, said William P. Sullivan, DO, an emergency physician and attorney in Frankfort, Ill.

As per the National Practitioner Data Bank, physicians are three to four times more likely to incur an adverse board action than make a malpractice payout, Dr. Sullivan said.

Also, although a malpractice lawsuit rarely involves more than a monetary payment, a board action, like a monitoring plan, can restrict your ability to practice medicine. In fact, any kind of board action against you can make it harder to find employment.
 

4. Not being honest or forthcoming

“Lying to the board is the fastest way to turn what would have been a minor infraction into putting your license at risk,” Mr. Brocker said. This can happen when doctors update a medical record to support their version of events.

As per Dr. Sullivan, another way to put your license at risk is to withhold adverse information, which the board can detect by obtaining your application for hospital privileges or for licensure to another state, in which you revealed the adverse information.

Dr. Sullivan also advised against claiming you “always” take a certain precautionary measure. “In reality, we doctors don’t always do what we would like to have done. By saying you always do it when you didn’t, you appear less than truthful to the board, and boards have a hard time with that.”

Similarly, “when doctors don’t want to recognize that they could have handled things better, they tend to dance around the issue,” Mr. Brocker said. “This does not sit well with the board.” Insisting that you did everything right when it’s obvious that you didn’t can lead to harsher sanctions. “The board wants to make sure doctors recognize their mistakes and are willing to learn from them.”
 

5. Providing too much information

You may think that providing a great deal of information strengthens your case, but it can actually weaken it, Mr. Brocker said. Irrelevant information makes your response hard to follow, and it may contain evidence that could prompt another line of inquiry.

“Less is more,” Dr. Segal advised. “Present a coherent argument and keep to the most salient points.” Being concise is also good advice if your complaint proceeds to the board and you have to present your case.

Dr. Segal said the board will stop paying attention to long-winded presentations. He tells his clients to imagine the board is watching a movie. “If your presentation is tedious or hard to follow, you will lose them.”
 

6. Trying to contact the complainant

Complaints are kept anonymous, but in many cases, the doctor has an idea who the complainant was and may try to contact that person. “It’s natural to wonder why a patient would file a complaint against you,” Mr. Brocker said, but if you reach out to the patient to ask why, “it could look like you’re trying to persuade the patient to drop the complaint.”

Doctors who are involved in a practice breakup or a divorce can be victims of false and malicious complaints, but Beth Y. Collis, a partner at the law firm of Dinsmore & Shohl in Columbus, said boards are onto this tactic and usually reject these complaints.

The doctor may be tempted to sue the complainant, but Mr. Brocker said this won’t stop the complaint and could strengthen it. “Most statements to the medical board are protected from defamation lawsuits, and any lawsuit could appear to be intimidation.”
 

 

 

7. Simply signing a consent agreement

A small minority of complaints may result in the board taking action against the doctor. Typically, this involves getting the doctor to sign a consent agreement stating that he or she agrees with the board’s decision and its remedy, such as continuing education, a fine, or being placed under another doctor’s supervision.

“When the board sends you a consent agreement, it’s usually about something fairly minor,” Ms. Collis said. “You can make a counteroffer and see if they accept that. But once you enter into the agreement, you waive any right to appeal the board’s decision.”
 

8. Not hiring an attorney

Although some doctors manage to deal with a board complaint on their own, many will need to get an attorney, Mr. Brocker said. “An experienced attorney can help you navigate the board’s process.”

Clients often look for attorneys at the end of the process, when formal charges have already been filed, Mr. Brocker said. At that point, “it’s harder to get things moving in the right direction. You can’t unring the bell.”

Even if you don’t think you need an attorney throughout the case, “it helps to get advice from an attorney at the beginning,” Dr. Segal said. Doctors may think they can’t afford an attorney, but many malpractice carriers pay attorneys’ fees in medical board investigations.

Mr. Brocker advised finding an attorney who is familiar with licensing boards. “Malpractice attorneys may think they can deal with medical boards, but boards are quite different.” For example, “malpractice cases involve an adversarial approach, but licensing boards normally require working collaboratively.”
 

9. Not requesting a hearing

When the board takes action against you, it can be tempting to just accept the allegations and move on with your life, but it may be possible to undo the action, Dr. Sullivan said. “The board still has to prove its allegations, and it may not have a strong case against you.”

In some states, the medical board has to meet a very high standard of proof, Dr. Sullivan said. In Illinois, for example, the board must show “clear and convincing evidence,” while a malpractice plaintiff must only prove that it’s “more likely than not” that a physician violated the standard of care.

A hearing can especially help doctors facing harsh sanctions for minor offenses. For example, in a case handled by the law firm of Ray & Bishop in Newport Beach, Calif., a doctor who was stopped by police while driving home after having wine at a family gathering was found to have a blood alcohol level of 0.11%. Noting that the physician was on call at the time, the Medical Board of California decided to give him 5 years of probation.

Ray & Bishop asked for a judicial hearing to contest the decision. At the hearing, the physician noted that other physicians were also available to take call that night, and an expert stated that the doctor was not an alcohol abuser. The judge ruled that the board’s action was unduly harsh, and the physician received a public reprimand with no further penalties.
 

 

 

10. Getting upset with board officials

A board investigator may show up at your office uninvited and ask you to answer some questions, but you aren’t required to answer then and there, said Ms. Collis.

In fact, she noted, it’s never a good idea to let investigators into your office. “They can walk around, look through your records, and find more things to investigate.” For this reason, Ms. Collis makes it a point to schedule meetings with investigators at her office.

When you have to interact with board officials, such as during hearings, expressing anger is a mistake. “Some board members may raise their voices and make untrue assertions about your medical care,” Dr. Sullivan said. “You may wish you could respond in kind, but that will not help you.” Instead, calmly provide studies or guidelines supporting the care you provided.

Taking board investigators to task is also a mistake, Mr. Brocker pointed out. In his words, “investigators have to follow the rules. Getting mad at them will only make your case more difficult. Even if you believe the complaint against you is totally without merit, the process needs to run its course.”

A version of this article first appeared on Medscape.com.

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What docs don’t know about the Disabilities Act can hurt them and patients

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Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

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Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

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CDC issues new pneumococcal vaccine recommendations for adults

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Wed, 02/09/2022 - 13:04

 

Updated pneumococcal vaccine recommendations for adults from the Centers for Disease Control and Prevention call for the use of the two recently approved vaccines in a more streamlined approach to avoid the complexities of age and patient conditions that hindered previous recommendations.

The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).

The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.

If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.

As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.

Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.

“As part of that process, ACIP strived to simplify the recommendations,” she said.

The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.

“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.

Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.

While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the

CDC does not recommend one over the other, Dr. Kobayashi noted.

More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.

Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.

“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”

The new approach should help change that, he said.

“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.

Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.

“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”

“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”

According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.

“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”

Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Updated pneumococcal vaccine recommendations for adults from the Centers for Disease Control and Prevention call for the use of the two recently approved vaccines in a more streamlined approach to avoid the complexities of age and patient conditions that hindered previous recommendations.

The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).

The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.

If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.

As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.

Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.

“As part of that process, ACIP strived to simplify the recommendations,” she said.

The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.

“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.

Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.

While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the

CDC does not recommend one over the other, Dr. Kobayashi noted.

More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.

Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.

“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”

The new approach should help change that, he said.

“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.

Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.

“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”

“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”

According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.

“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”

Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

Updated pneumococcal vaccine recommendations for adults from the Centers for Disease Control and Prevention call for the use of the two recently approved vaccines in a more streamlined approach to avoid the complexities of age and patient conditions that hindered previous recommendations.

The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).

The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.

If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.

As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.

Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.

“As part of that process, ACIP strived to simplify the recommendations,” she said.

The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.

“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.

Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.

While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the

CDC does not recommend one over the other, Dr. Kobayashi noted.

More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.

Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.

“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”

The new approach should help change that, he said.

“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.

Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.

“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”

“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”

According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.

“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”

Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Vitamin D shows no survival benefit in nondeficient elderly

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Monthly supplementation with vitamin D3 (cholecalciferol) in older adults without deficiency has no significant benefit in terms of survival outcomes, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.

“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.

Zbynek Pospisil/Getty Images

Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.

With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.

In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”

This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.

“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
 

D-Health Trial

The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.

Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).

They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.

Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).

There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).

Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.

An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”

Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.

Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
 

 

 

Findings supported by previous research

The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.

In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.

The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.

“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
 

Longer-term supplementation beneficial?

The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.

“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.

“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”

She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.

“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.

The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.

“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.

They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”

Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
 

Strategies still needed to address vitamin D deficiency

Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”

That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.

“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”

The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships. 


version of this article first appeared on Medscape.com.

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Monthly supplementation with vitamin D3 (cholecalciferol) in older adults without deficiency has no significant benefit in terms of survival outcomes, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.

“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.

Zbynek Pospisil/Getty Images

Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.

With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.

In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”

This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.

“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
 

D-Health Trial

The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.

Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).

They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.

Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).

There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).

Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.

An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”

Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.

Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
 

 

 

Findings supported by previous research

The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.

In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.

The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.

“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
 

Longer-term supplementation beneficial?

The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.

“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.

“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”

She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.

“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.

The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.

“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.

They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”

Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
 

Strategies still needed to address vitamin D deficiency

Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”

That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.

“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”

The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships. 


version of this article first appeared on Medscape.com.

Monthly supplementation with vitamin D3 (cholecalciferol) in older adults without deficiency has no significant benefit in terms of survival outcomes, including mortality linked to cardiovascular disease, new results from a large, placebo-controlled trial show.

“The take-home message is that routine vitamin D supplementation, irrespective of the dosing regimen, is unlikely to be beneficial in a population with a low prevalence of vitamin D deficiency,” first author Rachel E. Neale, PhD, of the Population Health Department, QIMR Berghofer Medical Research Institute, in Brisbane, Australia, told this news organization.

Zbynek Pospisil/Getty Images

Despite extensive previous research on vitamin D supplementation, “mortality has not been the primary outcome in any previous large trial of high-dose vitamin D supplementation,” Dr. Neale and coauthors noted. The results, published online in Lancet Diabetes & Endocrinology, are from the D-Health trial.

With more than 20,000 participants, this is the largest intermittent-dosing trial to date, the authors noted. The primary outcome was all-cause mortality.

In an accompanying editorial, Inez Schoenmakers, PhD, noted that “the findings [are] highly relevant for population policy, owing to the study’s population-based design, large scale, and long duration.”

This new “research contributes to the concept that improving vitamin D status with supplementation in a mostly vitamin D-replete older population does not influence all-cause mortality,” Dr. Schoenmakers, of the Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, England, said in an interview.

“This is not dissimilar to research with many other nutrients showing that increasing intake above the adequate intake has no further health benefits,” she added.
 

D-Health Trial

The D-Health Trial involved 21,315 participants in Australia, enrolled between February 2014 and June 2015, who had not been screened for vitamin D deficiency but were largely considered to be vitamin D replete. They were a mean age of 69.3 years and 54% were men.

Participants were randomized 1:1 to a once-monthly oral vitamin D3 supplementation of 60,000 IU (n = 10,662) or a placebo capsule (n = 10,653).

They were permitted to take up to 2,000 IU/day of supplemental vitamin D in addition to the study protocol and had no history of kidney stones, hypercalcemia, hyperparathyroidism, osteomalacia, or sarcoidosis.

Over a median follow-up of 5.7 years, there were 1,100 deaths: 562 in the vitamin D group (5.3%) and 538 in the placebo group (5.1%). With a hazard ratio (HR) for all-cause mortality of 1.04, the difference was not significant (P = .47).

There were also no significant differences in terms of mortality from cardiovascular disease (HR, 0.96; P = .77), cancer (HR, 1.15; P = .13), or other causes (HR, 0.83; P = .15).

Rates of total adverse events between the two groups, including hypercalcemia and kidney stones, were similar.

An exploratory analysis excluding the first 2 years of follow-up in fact showed a numerically higher hazard ratio for cancer mortality in the vitamin D group versus no supplementation (HR, 1.24; P = .05). However, the authors noted that the effect was “not apparent when the analysis was restricted to deaths that were coded by the study team and not officially coded.”

Nevertheless, “our findings, from a large study in an unscreened population, give pause to earlier reports that vitamin D supplements might reduce cancer mortality,” they underscored.

Retention and adherence in the study were high, each exceeding 80%. Although blood samples were not collected at baseline, samples from 3,943 randomly sampled participants during follow-up showed mean serum 25-hydroxy-vitamin D concentrations of 77 nmol/L in the placebo group and 115 nmol/L in the vitamin D group, both within the normal range of 50-125 nmol/L.
 

 

 

Findings supported by previous research

The trial results are consistent with those of prior large studies and meta-analyses of older adults with a low prevalence of vitamin D deficiency showing that vitamin D3 supplementation, regardless of whether taken daily or monthly, is not likely to have an effect on all-cause mortality.

In the US VITAL trial, recently published in the New England Journal of Medicine, among 25,871 participants administered 2,000 IU/day of vitamin D3 for a median of 5.3 years, there was no reduction in all-cause mortality.

The ViDA trial of 5,110 older adults in New Zealand, published in 2019 in the Journal of Endocrinological Investigation, also showed monthly vitamin D3 supplementation of 100,000 IU for a median of 3.3 years was not associated with a benefit in people who were not deficient.

“In total, the results from the large trials and meta-analyses suggest that routine supplementation of older adults in populations with a low prevalence of vitamin D deficiency is unlikely to reduce the rate of all-cause mortality,” Dr. Neale and colleagues concluded.
 

Longer-term supplementation beneficial?

The population was limited to older adults and the study had a relatively short follow-up period, which Dr. Neale noted was necessary for pragmatic reasons.

“Our primary outcome was all-cause mortality, so to have sufficient deaths we either needed to study older adults or a much larger sample of younger adults,” she explained.

“However, we felt that [the former] ... had biological justification, as there is evidence that vitamin D plays a role later in the course of a number of diseases, with potential impacts on mortality.”

She noted that recent studies evaluating genetically predicted concentrations of serum 25(OH)D have further shown no link between those levels and all-cause mortality, stroke, or coronary heart disease.

“This confirms the statement that vitamin D is unlikely to be beneficial in people who are not vitamin D deficient, irrespective of whether supplementation occurs over the short or longer term,” Dr. Neale said.

The source of vitamin D, itself, is another consideration, with ongoing speculation of differences in benefits between dietary or supplementation sources versus sunlight exposure.

“Exposure to ultraviolet radiation, for which serum 25(OH)D concentration is a good marker, might confer benefits not mediated by vitamin D,” Dr. Neale and coauthors noted.

They added that the results in the older Australian population “cannot be generalized to populations with a higher prevalence of vitamin D deficiency, or with a greater proportion of people not of White ancestry, than the study population.”

Ten-year mortality rates from the D-Health trial are expected to be reported in the future.
 

Strategies still needed to address vitamin D deficiency

Further commenting on the findings, Dr. Schoenmakers underscored that “vitamin D deficiency is very common worldwide, [and] more should be done to develop strategies to address the needs of those groups and populations that are at risk of the consequences of vitamin D deficiency.”

That said, the D-Health study is important in helping to distinguish when supplementation may – and may not – be of benefit, she noted.

“This and other research in the past 15 years have contributed to our understanding [of] what the ranges of vitamin D status are [in which] health consequences may be anticipated.”

The D-Health Trial was funded by the National Health and Medical Research Council. Dr. Neale and Dr. Schoenmakers have reported no relevant financial relationships. 


version of this article first appeared on Medscape.com.

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Omicron subvariant 1.5 times more contagious than Omicron

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Tue, 02/01/2022 - 10:36

The Omicron subvariant, known as BA.2, spreads about 1.5 times faster than the original Omicron strain, known as BA.1, according to CNBC.

The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.

BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.

The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.

Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.

On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.

A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.

The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.

“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.

The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.

“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.

“The big question is whether or not future variants will be more or less severe,” she said.

A version of this article first appeared on WebMD.com.

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The Omicron subvariant, known as BA.2, spreads about 1.5 times faster than the original Omicron strain, known as BA.1, according to CNBC.

The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.

BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.

The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.

Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.

On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.

A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.

The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.

“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.

The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.

“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.

“The big question is whether or not future variants will be more or less severe,” she said.

A version of this article first appeared on WebMD.com.

The Omicron subvariant, known as BA.2, spreads about 1.5 times faster than the original Omicron strain, known as BA.1, according to CNBC.

The Statens Serum Institut, which monitors infectious diseases in Denmark, said that BA.2 is more contagious, but it doesn’t appear to increase hospitalizations or reduce how well the vaccine works.

BA.2 overtook BA.1 as the primary variant in Denmark within a few weeks, Troels Lillebaek, director of the institute, told CNBC. The subvariant has five unique mutations on a key part of the spike protein, which is what the coronavirus uses to invade human cells. This often means a higher rate of spreading.

The Omicron subvariant has been detected in at least 29 states in the United States and 56 countries, according to the latest update from Outbreak.info. The United States has detected 188 infections, with the worldwide total nearing 25,000.

Denmark has reported the highest number of cases, followed by the United Kingdom and India. Both Denmark and India have reported that BA.2 now accounts for about half of new COVID-19 cases in those countries.

On Jan. 28, the U.K. Health Security Agency said BA.2 has a “substantial” growth advantage over the original Omicron strain. The subvariant has spread faster in all regions of England where there were enough cases to conduct an analysis, the agency said in a report.

A preliminary evaluation found that BA.2 doesn’t appear to change how well the vaccine works compared to the original Omicron strain, the agency said. A booster dose was 70% effective at preventing symptomatic illness for BA.2, compared with 63% for the original Omicron strain.

The Centers for Disease Control and Prevention also said on Jan. 28 that, although the subvariant has become more common in some countries, it is currently at a low level in the United States and doesn’t appear to be more serious.

“Currently there is no evidence that the BA.2 lineage is more severe than the BA.1 lineage,” Kristen Nordlund, a CDC spokesperson, told CNBC.

The World Health Organization hasn’t labeled BA.2 a “variant of concern” so far but will continue to monitor it. WHO officials have said that new variants will arise as Omicron spreads across the world.

“The next variant of concern will be more fit, and what we mean by that is it will be more transmissible because it will have to overtake what is currently circulating,” Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said during a livestream on Jan. 25.

“The big question is whether or not future variants will be more or less severe,” she said.

A version of this article first appeared on WebMD.com.

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Rheumatology News celebrates 20 years

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Wed, 04/20/2022 - 22:54

As Rheumatology News celebrates 20 years of publication in 2022, we’ll be taking a look back at rheumatology’s past and ahead to its future throughout the year. This time around, we’ll examine the first issue of Rheumatology News, which was published in February 2002. You can read the first-ever issue at the "PDF Download" link above.

In that premiere issue, information about early treatment of rheumatoid arthritis with tumor necrosis factor inhibitors and other disease-modifying antirheumatic drugs (DMARDs) featured prominently. A front-page story described new findings showing that early treatment of RA with DMARDs could reduce disease-related disability by one-third or more. A second article described quantitative improvement in MRI-detected synovitis in patients with early RA who were treated with infliximab for 14 weeks, while another reported on clinically relevant responses seen in 66% of patients treated with adalimumab plus methotrexate in a trial of patients with an inadequate response to methotrexate alone.

In other RA news, a report focused on low rates of preventive health care services and screening for other disorders in women, including Pap smears, mammograms, and influenza vaccinations. Another story suggested the possibility that methotrexate may elevate cancer risk in patients with RA. An analysis of two separate prospective studies indicated that women who regularly drink decaffeinated coffee may be at higher risk for developing RA.

Another page 1 story examined the potential of new drugs bosentan and epoprostenol for treating pulmonary arterial hypertension associated with various forms of connective tissue disease.

Etanercept was the focus of two articles, one announcing its approval for psoriatic arthritis, and another describing a small trial of the biologic in treating moderate to severe ankylosing spondylitis.

In osteoarthritis news, a front-page report described two placebo-controlled studies of oral glucosamine sulfate supplementation that suggested the formulation might slow the progression of joint space narrowing in postmenopausal women, and another article noted how a combined formulation of tramadol and acetaminophen reduced OA pain flares.

Readers were also treated to a pro and con editorial debate between Frederick Wolfe, MD, and Thomas J. Romano, MD, on whether trauma causes fibromyalgia.


Looking ahead

 

Throughout 2022, look for articles examining the past and future of rheumatology, including:

  • The rise of women in the field;
  • the rise of biologic and targeted synthetic disease-modifying antirheumatic drugs;
  • the history and ongoing influence of OMERACT (Outcome Measures in Rheumatology);
  • the growth and future of ACR-EULAR collaborations;
  • progress and future directions of pediatric rheumatology; and
  • the growth in understanding how sociodemographics and racial/ethnic identity affect access to and acceptance and receipt of rheumatologic care.

Are there any topics you think would be valuable to cover in light of Rheumatology News’ 20th anniversary? The editorial staff welcomes your suggestions. Please share them by emailing us at [email protected].

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Article PDF

As Rheumatology News celebrates 20 years of publication in 2022, we’ll be taking a look back at rheumatology’s past and ahead to its future throughout the year. This time around, we’ll examine the first issue of Rheumatology News, which was published in February 2002. You can read the first-ever issue at the "PDF Download" link above.

In that premiere issue, information about early treatment of rheumatoid arthritis with tumor necrosis factor inhibitors and other disease-modifying antirheumatic drugs (DMARDs) featured prominently. A front-page story described new findings showing that early treatment of RA with DMARDs could reduce disease-related disability by one-third or more. A second article described quantitative improvement in MRI-detected synovitis in patients with early RA who were treated with infliximab for 14 weeks, while another reported on clinically relevant responses seen in 66% of patients treated with adalimumab plus methotrexate in a trial of patients with an inadequate response to methotrexate alone.

In other RA news, a report focused on low rates of preventive health care services and screening for other disorders in women, including Pap smears, mammograms, and influenza vaccinations. Another story suggested the possibility that methotrexate may elevate cancer risk in patients with RA. An analysis of two separate prospective studies indicated that women who regularly drink decaffeinated coffee may be at higher risk for developing RA.

Another page 1 story examined the potential of new drugs bosentan and epoprostenol for treating pulmonary arterial hypertension associated with various forms of connective tissue disease.

Etanercept was the focus of two articles, one announcing its approval for psoriatic arthritis, and another describing a small trial of the biologic in treating moderate to severe ankylosing spondylitis.

In osteoarthritis news, a front-page report described two placebo-controlled studies of oral glucosamine sulfate supplementation that suggested the formulation might slow the progression of joint space narrowing in postmenopausal women, and another article noted how a combined formulation of tramadol and acetaminophen reduced OA pain flares.

Readers were also treated to a pro and con editorial debate between Frederick Wolfe, MD, and Thomas J. Romano, MD, on whether trauma causes fibromyalgia.


Looking ahead

 

Throughout 2022, look for articles examining the past and future of rheumatology, including:

  • The rise of women in the field;
  • the rise of biologic and targeted synthetic disease-modifying antirheumatic drugs;
  • the history and ongoing influence of OMERACT (Outcome Measures in Rheumatology);
  • the growth and future of ACR-EULAR collaborations;
  • progress and future directions of pediatric rheumatology; and
  • the growth in understanding how sociodemographics and racial/ethnic identity affect access to and acceptance and receipt of rheumatologic care.

Are there any topics you think would be valuable to cover in light of Rheumatology News’ 20th anniversary? The editorial staff welcomes your suggestions. Please share them by emailing us at [email protected].

As Rheumatology News celebrates 20 years of publication in 2022, we’ll be taking a look back at rheumatology’s past and ahead to its future throughout the year. This time around, we’ll examine the first issue of Rheumatology News, which was published in February 2002. You can read the first-ever issue at the "PDF Download" link above.

In that premiere issue, information about early treatment of rheumatoid arthritis with tumor necrosis factor inhibitors and other disease-modifying antirheumatic drugs (DMARDs) featured prominently. A front-page story described new findings showing that early treatment of RA with DMARDs could reduce disease-related disability by one-third or more. A second article described quantitative improvement in MRI-detected synovitis in patients with early RA who were treated with infliximab for 14 weeks, while another reported on clinically relevant responses seen in 66% of patients treated with adalimumab plus methotrexate in a trial of patients with an inadequate response to methotrexate alone.

In other RA news, a report focused on low rates of preventive health care services and screening for other disorders in women, including Pap smears, mammograms, and influenza vaccinations. Another story suggested the possibility that methotrexate may elevate cancer risk in patients with RA. An analysis of two separate prospective studies indicated that women who regularly drink decaffeinated coffee may be at higher risk for developing RA.

Another page 1 story examined the potential of new drugs bosentan and epoprostenol for treating pulmonary arterial hypertension associated with various forms of connective tissue disease.

Etanercept was the focus of two articles, one announcing its approval for psoriatic arthritis, and another describing a small trial of the biologic in treating moderate to severe ankylosing spondylitis.

In osteoarthritis news, a front-page report described two placebo-controlled studies of oral glucosamine sulfate supplementation that suggested the formulation might slow the progression of joint space narrowing in postmenopausal women, and another article noted how a combined formulation of tramadol and acetaminophen reduced OA pain flares.

Readers were also treated to a pro and con editorial debate between Frederick Wolfe, MD, and Thomas J. Romano, MD, on whether trauma causes fibromyalgia.


Looking ahead

 

Throughout 2022, look for articles examining the past and future of rheumatology, including:

  • The rise of women in the field;
  • the rise of biologic and targeted synthetic disease-modifying antirheumatic drugs;
  • the history and ongoing influence of OMERACT (Outcome Measures in Rheumatology);
  • the growth and future of ACR-EULAR collaborations;
  • progress and future directions of pediatric rheumatology; and
  • the growth in understanding how sociodemographics and racial/ethnic identity affect access to and acceptance and receipt of rheumatologic care.

Are there any topics you think would be valuable to cover in light of Rheumatology News’ 20th anniversary? The editorial staff welcomes your suggestions. Please share them by emailing us at [email protected].

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Buprenorphine may curb opioid-induced respiratory depression

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Changed
Tue, 02/01/2022 - 10:01

High plasma concentrations of buprenorphine may reduce fentanyl-induced respiratory depression, new research suggests.

The primary endpoint measure in a small “proof of principal” pharmacology study was effect of escalating fentanyl dosing on respiratory depression by way of decreased isohypercapnic minute ventilation (VE) – or volume of gas inhaled or exhaled per minute from the lungs.

sdominick/iStock/Getty Images

Results showed the maximum decrease in highest-dose fentanyl-induced VE was almost 50% less for opioid-tolerant patients receiving a 2.0 ng/mL concentration of steady-state plasma buprenorphine than when receiving matching placebo.

Risk for apnea requiring stimulation after fentanyl dosing was also significantly lower with buprenorphine.

“Even though the study is small, a lot of data were collected which will allow us to very accurately predict which plasma concentrations, and therefore drug doses, are needed to protect people adequately in practice,” study coinvestigator Geert Jan Groeneveld, MD, PhD, neurologist and clinical pharmacologist at the Centre for Human Drug Research, Leiden, the Netherlands, and professor of clinical neuropharmacology at Leiden University Medical Center, told this news organization.

He added the “beautiful results” were in line with what the researchers expected and although further research is needed, the study provides a lot of useful information for clinicians.

“I think this is an approach that works, and this study makes that clear,” Dr. Groeneveld added.

The findings were published online Jan. 27, 2022, in PLoS One.
 

High death rate from synthetic opioids

recent report from the Centers for Disease Control and Prevention noted that, between June 2020 and June 2021, there were more than 100,000 drug overdose deaths in the United States. Of these, more than 73,000 were attributed to opioids and more than 60,000 to synthetic opioids such as fentanyl.

Most opioid-related overdose deaths in the United States are attributable to synthetic opioids “that can unexpectedly cause respiratory depression by being ingested as a substitute for heroin or with [other] drugs,” Indivior noted in a press release.

Buprenorphine is a partial agonist that “binds with high affinity to mu-opioid receptors but displays partial respiratory depression effects,” the investigators wrote.

As reported by this news organization, the Food and Drug Administration approved buprenorphine extended release (Sublocade, Indivior) in 2017 as the first once-monthly injection for the treatment of opioid use disorder.

In the current study, which was conducted in Leiden, the Netherlands, the investigators used continuous intravenous buprenorphine in order to “mimic” the sustained plasma concentrations of the drug that can be delivered with the long-acting injectable, noted Christian Heidbreder, PhD, chief scientific officer at Indivior.

“This was an experimental medicine study, whereby we used intravenous buprenorphine to really understand the interaction with escalating doses of fentanyl” on respiratory depression, he told this news organization.
 

Two-part, two-period study

In part A, period one of the two-period crossover study, 14 healthy volunteers were randomly assigned to receive for 360 minutes continuous infusion of 0.02 or 0.05 mg/70 kg per hour of buprenorphine to target plasma concentrations of 0.2 or 0.5 ng/mL, respectively, or matching placebo. In the second period, participants received the alternative infusion – either placebo or the active drug.

In part B, eight opioid-tolerant patients who had used high-dose opioids for at least 3 months prior received a higher infusion rate of 0.1, 0.2, or 0.5 mg/70 kg per hour to target plasma concentrations of 1, 2, or 5 ng/mL, respectively.

The 2 ng/mL “is a very important threshold for us” and the result from several previous experiments, Dr. Heidbreder noted. So the investigators targeted that concentration as well as one below and one “much higher” in the current study.

“Because tolerance to opioid effects is poorly characterized in patients receiving long-term opioids, opioid-tolerant participants in part B had a fixed treatment sequence, receiving placebo infusion plus fentanyl challenges in period 1 to optimize the fentanyl dose escalation before buprenorphine and fentanyl were coadministered in period 2,” the investigators reported.

All participants received up to four escalating doses of intravenous fentanyl after reaching target buprenorphine plasma concentrations.

For healthy volunteers, the planned fentanyl doses were 0.075, 0.15, 0.25, and 0.35 mg/70 kg. For the opioid-tolerant patients, the doses were 0.25, 0.35, 0.5, and 0.7 mg/70 kg.

The infusions began after baseline VE had stabilized at 20 plus or minus 2 L/min, which is about four times above normal resting VE.
 

First clinical evidence?

Results showed fentanyl-induced adverse changes in VE were less at higher concentrations of buprenorphine plasma.

Opioid-tolerant patients receiving the 2.0 ng/mL concentration of buprenorphine had a 33.7% decrease in highest dose fentanyl-induced VE versus an 82.3% decrease when receiving placebo.

In addition, fentanyl reduced VE up to 49% (95% confidence interval, 21%-76%) in opioid-tolerant patients in all buprenorphine concentration groups combined versus reducing VE up to 100% (95% CI, 68%-132%) during placebo infusion (P = .006).

In addition, buprenorphine was associated with a lower risk versus placebo for apnea requiring verbal stimulation after fentanyl dosing (odds ratio, 0.07; P = .001).

For the healthy volunteers, the first fentanyl bolus reduced VE by 26% for those at target buprenorphine concentration of 0.5 ng/mL versus 51% when receiving placebo (P = .001). The second bolus reduced VE by 47% versus 79%, respectively (P < .001).

“Discontinuations for apnea limited treatment comparisons beyond the second fentanyl injection,” the investigators reported.

Overall, the findings “provide the first clinical evidence that high sustained plasma concentrations of buprenorphine may protect against respiratory depression induced by potent opioids,” they added.

Additional research is now “warranted to assess the competitive interaction of buprenorphine and fentanyl (as well as other illicitly manufactured fentanyl analogs) as we continue to deepen our understanding of buprenorphine as an evidence-based treatment for patients struggling with opioid use disorder,” Dr. Heidbreder said in a press release.

It’s unclear whether the study’s findings are generalizable to other populations, said Dr. Heidbreder.

“So what we are going to do next is to see what is actually happening in a real world, much broader patient population; and for that we’ll be using [the injectable] Sublocade as the medication of choice,” said Dr. Heidbreder.

“Conceptually, we feel confident about these data, but now we need to demonstrate what is happening in the real world,” he added.

The study was funded by Indivior. Dr. Groeneveld has reported no relevant financial relationships. Dr. Heidbreder is an employee of Indivior.

A version of this article first appeared on Medscape.com.

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High plasma concentrations of buprenorphine may reduce fentanyl-induced respiratory depression, new research suggests.

The primary endpoint measure in a small “proof of principal” pharmacology study was effect of escalating fentanyl dosing on respiratory depression by way of decreased isohypercapnic minute ventilation (VE) – or volume of gas inhaled or exhaled per minute from the lungs.

sdominick/iStock/Getty Images

Results showed the maximum decrease in highest-dose fentanyl-induced VE was almost 50% less for opioid-tolerant patients receiving a 2.0 ng/mL concentration of steady-state plasma buprenorphine than when receiving matching placebo.

Risk for apnea requiring stimulation after fentanyl dosing was also significantly lower with buprenorphine.

“Even though the study is small, a lot of data were collected which will allow us to very accurately predict which plasma concentrations, and therefore drug doses, are needed to protect people adequately in practice,” study coinvestigator Geert Jan Groeneveld, MD, PhD, neurologist and clinical pharmacologist at the Centre for Human Drug Research, Leiden, the Netherlands, and professor of clinical neuropharmacology at Leiden University Medical Center, told this news organization.

He added the “beautiful results” were in line with what the researchers expected and although further research is needed, the study provides a lot of useful information for clinicians.

“I think this is an approach that works, and this study makes that clear,” Dr. Groeneveld added.

The findings were published online Jan. 27, 2022, in PLoS One.
 

High death rate from synthetic opioids

recent report from the Centers for Disease Control and Prevention noted that, between June 2020 and June 2021, there were more than 100,000 drug overdose deaths in the United States. Of these, more than 73,000 were attributed to opioids and more than 60,000 to synthetic opioids such as fentanyl.

Most opioid-related overdose deaths in the United States are attributable to synthetic opioids “that can unexpectedly cause respiratory depression by being ingested as a substitute for heroin or with [other] drugs,” Indivior noted in a press release.

Buprenorphine is a partial agonist that “binds with high affinity to mu-opioid receptors but displays partial respiratory depression effects,” the investigators wrote.

As reported by this news organization, the Food and Drug Administration approved buprenorphine extended release (Sublocade, Indivior) in 2017 as the first once-monthly injection for the treatment of opioid use disorder.

In the current study, which was conducted in Leiden, the Netherlands, the investigators used continuous intravenous buprenorphine in order to “mimic” the sustained plasma concentrations of the drug that can be delivered with the long-acting injectable, noted Christian Heidbreder, PhD, chief scientific officer at Indivior.

“This was an experimental medicine study, whereby we used intravenous buprenorphine to really understand the interaction with escalating doses of fentanyl” on respiratory depression, he told this news organization.
 

Two-part, two-period study

In part A, period one of the two-period crossover study, 14 healthy volunteers were randomly assigned to receive for 360 minutes continuous infusion of 0.02 or 0.05 mg/70 kg per hour of buprenorphine to target plasma concentrations of 0.2 or 0.5 ng/mL, respectively, or matching placebo. In the second period, participants received the alternative infusion – either placebo or the active drug.

In part B, eight opioid-tolerant patients who had used high-dose opioids for at least 3 months prior received a higher infusion rate of 0.1, 0.2, or 0.5 mg/70 kg per hour to target plasma concentrations of 1, 2, or 5 ng/mL, respectively.

The 2 ng/mL “is a very important threshold for us” and the result from several previous experiments, Dr. Heidbreder noted. So the investigators targeted that concentration as well as one below and one “much higher” in the current study.

“Because tolerance to opioid effects is poorly characterized in patients receiving long-term opioids, opioid-tolerant participants in part B had a fixed treatment sequence, receiving placebo infusion plus fentanyl challenges in period 1 to optimize the fentanyl dose escalation before buprenorphine and fentanyl were coadministered in period 2,” the investigators reported.

All participants received up to four escalating doses of intravenous fentanyl after reaching target buprenorphine plasma concentrations.

For healthy volunteers, the planned fentanyl doses were 0.075, 0.15, 0.25, and 0.35 mg/70 kg. For the opioid-tolerant patients, the doses were 0.25, 0.35, 0.5, and 0.7 mg/70 kg.

The infusions began after baseline VE had stabilized at 20 plus or minus 2 L/min, which is about four times above normal resting VE.
 

First clinical evidence?

Results showed fentanyl-induced adverse changes in VE were less at higher concentrations of buprenorphine plasma.

Opioid-tolerant patients receiving the 2.0 ng/mL concentration of buprenorphine had a 33.7% decrease in highest dose fentanyl-induced VE versus an 82.3% decrease when receiving placebo.

In addition, fentanyl reduced VE up to 49% (95% confidence interval, 21%-76%) in opioid-tolerant patients in all buprenorphine concentration groups combined versus reducing VE up to 100% (95% CI, 68%-132%) during placebo infusion (P = .006).

In addition, buprenorphine was associated with a lower risk versus placebo for apnea requiring verbal stimulation after fentanyl dosing (odds ratio, 0.07; P = .001).

For the healthy volunteers, the first fentanyl bolus reduced VE by 26% for those at target buprenorphine concentration of 0.5 ng/mL versus 51% when receiving placebo (P = .001). The second bolus reduced VE by 47% versus 79%, respectively (P < .001).

“Discontinuations for apnea limited treatment comparisons beyond the second fentanyl injection,” the investigators reported.

Overall, the findings “provide the first clinical evidence that high sustained plasma concentrations of buprenorphine may protect against respiratory depression induced by potent opioids,” they added.

Additional research is now “warranted to assess the competitive interaction of buprenorphine and fentanyl (as well as other illicitly manufactured fentanyl analogs) as we continue to deepen our understanding of buprenorphine as an evidence-based treatment for patients struggling with opioid use disorder,” Dr. Heidbreder said in a press release.

It’s unclear whether the study’s findings are generalizable to other populations, said Dr. Heidbreder.

“So what we are going to do next is to see what is actually happening in a real world, much broader patient population; and for that we’ll be using [the injectable] Sublocade as the medication of choice,” said Dr. Heidbreder.

“Conceptually, we feel confident about these data, but now we need to demonstrate what is happening in the real world,” he added.

The study was funded by Indivior. Dr. Groeneveld has reported no relevant financial relationships. Dr. Heidbreder is an employee of Indivior.

A version of this article first appeared on Medscape.com.

High plasma concentrations of buprenorphine may reduce fentanyl-induced respiratory depression, new research suggests.

The primary endpoint measure in a small “proof of principal” pharmacology study was effect of escalating fentanyl dosing on respiratory depression by way of decreased isohypercapnic minute ventilation (VE) – or volume of gas inhaled or exhaled per minute from the lungs.

sdominick/iStock/Getty Images

Results showed the maximum decrease in highest-dose fentanyl-induced VE was almost 50% less for opioid-tolerant patients receiving a 2.0 ng/mL concentration of steady-state plasma buprenorphine than when receiving matching placebo.

Risk for apnea requiring stimulation after fentanyl dosing was also significantly lower with buprenorphine.

“Even though the study is small, a lot of data were collected which will allow us to very accurately predict which plasma concentrations, and therefore drug doses, are needed to protect people adequately in practice,” study coinvestigator Geert Jan Groeneveld, MD, PhD, neurologist and clinical pharmacologist at the Centre for Human Drug Research, Leiden, the Netherlands, and professor of clinical neuropharmacology at Leiden University Medical Center, told this news organization.

He added the “beautiful results” were in line with what the researchers expected and although further research is needed, the study provides a lot of useful information for clinicians.

“I think this is an approach that works, and this study makes that clear,” Dr. Groeneveld added.

The findings were published online Jan. 27, 2022, in PLoS One.
 

High death rate from synthetic opioids

recent report from the Centers for Disease Control and Prevention noted that, between June 2020 and June 2021, there were more than 100,000 drug overdose deaths in the United States. Of these, more than 73,000 were attributed to opioids and more than 60,000 to synthetic opioids such as fentanyl.

Most opioid-related overdose deaths in the United States are attributable to synthetic opioids “that can unexpectedly cause respiratory depression by being ingested as a substitute for heroin or with [other] drugs,” Indivior noted in a press release.

Buprenorphine is a partial agonist that “binds with high affinity to mu-opioid receptors but displays partial respiratory depression effects,” the investigators wrote.

As reported by this news organization, the Food and Drug Administration approved buprenorphine extended release (Sublocade, Indivior) in 2017 as the first once-monthly injection for the treatment of opioid use disorder.

In the current study, which was conducted in Leiden, the Netherlands, the investigators used continuous intravenous buprenorphine in order to “mimic” the sustained plasma concentrations of the drug that can be delivered with the long-acting injectable, noted Christian Heidbreder, PhD, chief scientific officer at Indivior.

“This was an experimental medicine study, whereby we used intravenous buprenorphine to really understand the interaction with escalating doses of fentanyl” on respiratory depression, he told this news organization.
 

Two-part, two-period study

In part A, period one of the two-period crossover study, 14 healthy volunteers were randomly assigned to receive for 360 minutes continuous infusion of 0.02 or 0.05 mg/70 kg per hour of buprenorphine to target plasma concentrations of 0.2 or 0.5 ng/mL, respectively, or matching placebo. In the second period, participants received the alternative infusion – either placebo or the active drug.

In part B, eight opioid-tolerant patients who had used high-dose opioids for at least 3 months prior received a higher infusion rate of 0.1, 0.2, or 0.5 mg/70 kg per hour to target plasma concentrations of 1, 2, or 5 ng/mL, respectively.

The 2 ng/mL “is a very important threshold for us” and the result from several previous experiments, Dr. Heidbreder noted. So the investigators targeted that concentration as well as one below and one “much higher” in the current study.

“Because tolerance to opioid effects is poorly characterized in patients receiving long-term opioids, opioid-tolerant participants in part B had a fixed treatment sequence, receiving placebo infusion plus fentanyl challenges in period 1 to optimize the fentanyl dose escalation before buprenorphine and fentanyl were coadministered in period 2,” the investigators reported.

All participants received up to four escalating doses of intravenous fentanyl after reaching target buprenorphine plasma concentrations.

For healthy volunteers, the planned fentanyl doses were 0.075, 0.15, 0.25, and 0.35 mg/70 kg. For the opioid-tolerant patients, the doses were 0.25, 0.35, 0.5, and 0.7 mg/70 kg.

The infusions began after baseline VE had stabilized at 20 plus or minus 2 L/min, which is about four times above normal resting VE.
 

First clinical evidence?

Results showed fentanyl-induced adverse changes in VE were less at higher concentrations of buprenorphine plasma.

Opioid-tolerant patients receiving the 2.0 ng/mL concentration of buprenorphine had a 33.7% decrease in highest dose fentanyl-induced VE versus an 82.3% decrease when receiving placebo.

In addition, fentanyl reduced VE up to 49% (95% confidence interval, 21%-76%) in opioid-tolerant patients in all buprenorphine concentration groups combined versus reducing VE up to 100% (95% CI, 68%-132%) during placebo infusion (P = .006).

In addition, buprenorphine was associated with a lower risk versus placebo for apnea requiring verbal stimulation after fentanyl dosing (odds ratio, 0.07; P = .001).

For the healthy volunteers, the first fentanyl bolus reduced VE by 26% for those at target buprenorphine concentration of 0.5 ng/mL versus 51% when receiving placebo (P = .001). The second bolus reduced VE by 47% versus 79%, respectively (P < .001).

“Discontinuations for apnea limited treatment comparisons beyond the second fentanyl injection,” the investigators reported.

Overall, the findings “provide the first clinical evidence that high sustained plasma concentrations of buprenorphine may protect against respiratory depression induced by potent opioids,” they added.

Additional research is now “warranted to assess the competitive interaction of buprenorphine and fentanyl (as well as other illicitly manufactured fentanyl analogs) as we continue to deepen our understanding of buprenorphine as an evidence-based treatment for patients struggling with opioid use disorder,” Dr. Heidbreder said in a press release.

It’s unclear whether the study’s findings are generalizable to other populations, said Dr. Heidbreder.

“So what we are going to do next is to see what is actually happening in a real world, much broader patient population; and for that we’ll be using [the injectable] Sublocade as the medication of choice,” said Dr. Heidbreder.

“Conceptually, we feel confident about these data, but now we need to demonstrate what is happening in the real world,” he added.

The study was funded by Indivior. Dr. Groeneveld has reported no relevant financial relationships. Dr. Heidbreder is an employee of Indivior.

A version of this article first appeared on Medscape.com.

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FDA grants full approval to Moderna COVID-19 vaccine

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Wed, 02/02/2022 - 14:36

Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.

The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.

The Moderna vaccine also now has a new trade name: Spikevax.

The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.

The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.

Spikevax is the first Moderna product to be fully licensed in the United States.

The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.

“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.

A version of this article first appeared on WebMD.com.

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Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.

The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.

The Moderna vaccine also now has a new trade name: Spikevax.

The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.

The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.

Spikevax is the first Moderna product to be fully licensed in the United States.

The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.

“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.

A version of this article first appeared on WebMD.com.

Moderna announced today that its mRNA COVID-19 vaccine has received full Food and Drug Administration approval for adults 18 years and older.

The move lifts an FDA emergency use authorization for the vaccine, which started Dec. 18, 2020.

The Moderna vaccine also now has a new trade name: Spikevax.

The FDA approval comes a little more than 5 months after the agency granted full approval to the Pfizer/BioNTech COVID-19 vaccine on Aug. 23. At the time, the Pfizer vaccine received the trade name Comirnaty.

The FDA approved the Moderna vaccine based on how well it works and its safety for 6 months after a second dose, including follow-up data from a phase 3 study, Moderna announced this morning through a news release. The FDA also announced the news.

Spikevax is the first Moderna product to be fully licensed in the United States.

The United States joins more than 70 other countries where regulators have approved the vaccine. A total of 807 million doses of Moderna’s COVID-19 vaccine were shipped worldwide in 2021, the company reported.

“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries, where the adolescent indication is also approved,” Stéphane Bancel, Moderna chief executive officer, said in the release.

A version of this article first appeared on WebMD.com.

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Billionaire Mark Cuban launches online pharmacy for generics

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Fri, 02/04/2022 - 11:04

 

Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

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Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

 

Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

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