Bloomberg Businessweek - USA (2019-06-17)

◼ BUSINESS June 17, 2019

21

THEBOTTOMLINE AstraZeneca,whichtypicallydevelopshigh-

pricedmedicines,haspartneredwitha Chinesecompanytomarket

onebasedonredyeastrice.

in that it contains a documented active substance.

“We’re pretty sure we know what’s in it and how it

works,whichis rarefora botanicaldietarysupple-

ment,”saysHopp,theNIHscientist.

Still,somescientistshavesaidthere’sa lack

ofreliableresearchintoXuezhikang.Studiesof

traditionalChinesetreatmentsareoftenofpoor

quality,accordingtoNIH’sNationalCenterfor

ComplementaryandIntegrativeHealth.Ina 2012

analysisof 22 studiesofXuezhikangforhighcholes-

terol,mostfailedtoshowthey’dassignedpatients

randomlytoa treatmentgroup,a keystepinremov-

ingbias.OneofthetestswastheChinaCoronary

SecondaryPreventionStudy,whichreportedpos-

itiveresults.“Morerigoroustrialswithhighqual-

ityareneeded,”theauthorsconcluded,“especially

forcomparingtheeffectivenessandsafetybetween

Xuezhikangandstatins.”

KirstinWeiderwasa residentphysicianatan

internalmedicineprogramintheU.S.lastyear

whena 64-year-oldwomancametothehospital

sayingshe’dbeentiredandhadlostherappetite.

Thewomanhadrecentlybeendiagnosedwith

highcholesteroland,waryoftakinga prescription

drug,decidedtotakea supplement:redyeastrice.

Testsshowedthewomanwassufferingsevere

liverdamage.Doctorsstoppedherfromtaking

thesupplementandgaveheranti-inflammatory

treatment,andsherecovered.“Wewerelucky

thatwecaughtit ata goodtime,”saysWeider,

whoco-wrotea recentarticleontheepisodein

BMJCaseReports. “Itcouldhavepotentiallyhada

worseoutcome.”

Dobber,Astra’sbiopharmaceuticalunitchief,

saysthecompanyis followingstandardsafetypro-

tocolsasit developsXuezhikang.“Allthiswillbe

donewiththestandardsofAstraZeneca,”hesays.

“We’llnevercompromisewiththesafetyaspects.”

�JohnLauerman,withDongLyuandTomMetcalf

says Craig Hopp, deputy director of extramural
research at the division of the U.S. National Institutes
ofHealththat studiesalternativetreatments.
Asupplyof 12 capsulesofXuezhikangcosts
17 yuan($2.50)onthewebsiteofChineseonline
retailerJD.com. Saleswere about$26million
in2018,accordingtohealth-caredatafromIQVIA
HoldingsInc.,a fractionofthe$2.4billion revenue
in China for cholesterol drugs.
Xuezhikang’s packaging materials say it treats
hyperlipidemia, a condition where the blood
contains high levels of fat particles such as cho-
lesterol, as well as a host of symptoms ranging
from dizziness to anorexia. The drug’s effec-
tivenesscomesfrommonacolins,chemicalsin
redyeastricethatresemblestatins—aclassof
cholesterol-lowering drugsthathaveranked
amongthepharmaindustry’smostprofitable.
(AstramakesthestatinCrestor.)
Europeandrugofficialshaven’tclearedred
yeastriceortheextract,anda bodythatregulates
supplements there warns against their use,
particularlywithoutconsultinga physician.The
U.S.FoodandDrugAdministrationsaysredyeast
riceshouldn’tbeusedasa substituteforstandard
hearttreatments.
Otherthanthepurchasesixyearsagoofa
drugbasedonchemicalsinfishoilsthathasn’t
recordedsalessofar,Astra’sfocushasbeenfirmly
oninnovatingmedicinesinthelab.EvenLuye,
foundedin 1994 byChinesebillionaireLiuDian
Bo,ismovingtowarddevisingnewtreatments.
Justlastmonthitsoughtpermissionfromthe
FDAtosella drugforschizophreniaandbipolar
disorder.Amongitsmoreadvancedexperimen-
talprojectsis a collaborationwitha U.S.biotech
ona therapyforprogrammingimmunecellsto
attackcancers.
Onitswebsite,LuyecallsXuezhikang“thefirst
evidence-basedandinternationallyrecognized
Chineselipid-adjusting drug which has completed
phase II clinical trials required by FDA.” The com-
pany points to studies indicating that it reduces
cholesterol with greater safety than statins. But the
approach isn’t without risk: Monacolins are linked
to the same side effects as those widely used med-
icines, which can include liver damage and rare
cases of muscle tissue breakdown.
While China has revamped regulation of con-
ventional medicines, its National Medical Products
Administration doesn’t require many traditional
therapies to undergo randomized clinical trials for
approval. These studies are the standard in the U.S.
and Europe for ensuring safety and effectiveness.
Red yeast rice is unusual among supplements

● 2018 China sales of

Xuezhikang, an extract

of red yeast rice

$26m

◀ Red yeast rice