US drug company = warned over ad featuring =91Magic=92 Johnson - World, Business

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Common medical =91myths=92 = exposed in new=20 book | See Latest = News=20 |

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US drug company warned over ad featuring =91Magic=92 Johnson

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In the video Magic Johnson was interviewed about the = benefits=20 of Kaletra Photo: Getty Images

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World=20 Home

By Catherine Larkin

Thursday July 23 2009

Abbott= =20 Laboratories was warned by US = regulators over a=20 promotional DVD where basketball Hall of Fame member Earvin "Magic" = Johnson=20 discusses his experience with the HIV treatment Kaletra.

The consumer-directed video =93minimizes the serious risks=94 and = =93overstates the=20 efficacy=94 of the medicine, the Fo= od and=20 Drug Administration said in a warning letter posted today on the = agency=92s=20 website.

Abbott stopped using the DVD earlier this year and will work with the = FDA to=20 address its concerns, according to Michelle = Johnson, a=20 company spokeswoman.

Abbott was warned in 2004 over a print advertisement for Kaletra that = failed=20 to include risk information and implied that patients can expect to be = healthy=20 for at least five years, which hasn=92t been proven, according to the = letter.

The FDA said it is concerned that the drugmaker is continuing to use=20 promotions for the drug that are misleading and in violation of federal = law.=20

=93The violations described above are serious,=94 Thomas = Abrams,=20 director of the FDA=92s division of drug marketing, wrote in the letter. =

Abbott was ordered to submit to the agency a plan to =93disseminate = truthful,=20 non-misleading, and complete corrective messages about the issues = discussed in=20 this letter.=94

Johnson video interview

In the video Magic Johnson was interviewed about the benefits of = Kaletra for=20 the first 11 1/2 minutes, according to the letter.

A discussion of the drug=92s risks was left until the end of the DVD = as a=20 running telescript, =93where it is unlikely to draw the viewer=92s = attention,=94 the=20 FDA said.

The agency also took issue with implication that all patients fare as = well as=20 Johnson, a 49-year-old retired professional basketball player who = announced that=20 he had HIV in 1991.

In the DVD, Johnson said his disease has been undetectable in the = five years=20 since he started taking Kaletra.

=93FDA is not aware of substantial evidence or substantial clinical = experience=20 to support effectiveness for five or more years of treatment with = Kaletra in=20 treatment-experienced adults,=94 the FDA said in the letter.

=93The personal experience of a Kaletra patient such as Magic Johnson = does not=20 constitute such evidence.=94

Johnson was a five-time National=20 Basketball Association champion with the Los Angeles = Lakers and a three-time league Most Valuable Player.

Kaletra is Abbott=92s second biggest drug, accounting for $1.47bn = (=801.03bn) in=20 2008 sales, or 5pc of the company=92s revenue, according to data = compiled by=20 Bloomberg.

(Bloomberg)

- Catherine Larkin

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values",version:"1.7.2",eventPrefix:"slide",defaults:{animate:false,delay= :0,distance:0,max:100,min:0,orientation:"horizontal",range:false,step:1,v= alue:0,values:null}})})(jQuery);; /* * jQuery UI Datepicker 1.7.2 * * Copyright (c) 2009 AUTHORS.txt (http://jqueryui.com/about) * Dual licensed under the MIT (MIT-LICENSE.txt) * and GPL (GPL-LICENSE.txt) licenses. * * http://docs.jquery.com/UI/Datepicker * * Depends: * ui.core.js */ (function($){$.extend($.ui,{datepicker:{version:"1.7.2"}});var = PROP_NAME=3D"datepicker";function = Datepicker(){this.debug=3Dfalse;this._curInst=3Dnull;this._keyEvent=3Dfal= se;this._disabledInputs=3D[];this._datepickerShowing=3Dfalse;this._inDial= og=3Dfalse;this._mainDivId=3D"ui-datepicker-div";this._inlineClass=3D"ui-= datepicker-inline";this._appendClass=3D"ui-datepicker-append";this._trigg= erClass=3D"ui-datepicker-trigger";this._dialogClass=3D"ui-datepicker-dial= og";this._disableClass=3D"ui-datepicker-disabled";this._unselectableClass= =3D"ui-datepicker-unselectable";this._currentClass=3D"ui-datepicker-curre= nt-day";this._dayOverClass=3D"ui-datepicker-days-cell-over";this.regional= =3D[];this.regional[""]=3D{closeText:"Done",prevText:"Prev",nextText:"Nex= t",currentText:"Today",monthNames:["January","February","March","April","= May","June","July","August","September","October","November","December"],= monthNamesShort:["Jan","Feb","Mar","Apr","May","Jun","Jul","Aug","Sep","O= ct","Nov","Dec"],dayNames:["Sunday","Monday","Tuesday","Wednesday","Thurs= day","Friday","Saturday"],dayNamesShort:["Sun","Mon","Tue","Wed","Thu","F= ri","Sat"],dayNamesMin:["Su","Mo","Tu","We","Th","Fr","Sa"],dateFormat:"m= m/dd/yy",firstDay:0,isRTL:false};this._defaults=3D{showOn:"focus",showAni= m:"show",showOptions:{},defaultDate:null,appendText:"",buttonText:"...",b= uttonImage:"",buttonImageOnly:false,hideIfNoPrevNext:false,navigationAsDa= teFormat:false,gotoCurrent:false,changeMonth:false,changeYear:false,showM= onthAfterYear:false,yearRange:"-10:+10",showOtherMonths:false,calculateWe= ek:this.iso8601Week,shortYearCutoff:"+10",minDate:null,maxDate:null,durat= ion:"normal",beforeShowDay:null,beforeShow:null,onSelect:null,onChangeMon= thYear:null,onClose:null,numberOfMonths:1,showCurrentAtPos:0,stepMonths:1= ,stepBigMonths:12,altField:"",altFormat:"",constrainInput:true,showButton= Panel:false};$.extend(this._defaults,this.regional[""]);this.dpDiv=3D$('<= div id=3D"'+this._mainDivId+'" class=3D"ui-datepicker ui-widget = ui-widget-content ui-helper-clearfix ui-corner-all = ui-helper-hidden-accessible">


=3D5?" = ui-datepicker-week-end":"")+(otherMonth?" = ui-datepicker-other-month":"")+((printDate.getTime()=3D=3DselectedDate.ge= tTime()&&drawMonth=3D=3Dinst.selectedMonth&&inst._keyEvent)\|\|(defaultDate= .getTime()=3D=3DprintDate.getTime()&&defaultDate.getTime()=3D=3DselectedD= ate.getTime())?" "+this._dayOverClass:"")+(unselectable?" = "+this._unselectableClass+" = ui-state-disabled":"")+(otherMonth&&!showOtherMonths?"":" = "+daySettings[1]+(printDate.getTime()>=3DcurrentDate.getTime()&&printDate= .getTime()<=3DendDate.getTime()?" = "+this._currentClass:"")+(printDate.getTime()=3D=3Dtoday.getTime()?" = ui-datepicker-today":""))+'"'+((!otherMonth\|\|showOtherMonths)&&daySetting= s[2]?' title=3D"'+daySettings[2]+'"':"")+(unselectable?"":" = onclick=3D\"DP_jQuery.datepicker._selectDay('#"+inst.id+"',"+drawMonth+",= "+drawYear+', this);return = false;"')+">"+(otherMonth?(showOtherMonths?printDate.getDate():" "):= (unselectable?''+printDate.getDate()+"":'=3DcurrentDate.getTime()&&pr= intDate.getTime()<=3DendDate.getTime()?" ui-state-active":"")+'" = href=3D"#">'+printDate.getDate()+""))+"

=3D5?" = ui-datepicker-week-end":"")+(otherMonth?" = ui-datepicker-other-month":"")+((printDate.getTime()=3D=3DselectedDate.ge= tTime()&&drawMonth=3D=3Dinst.selectedMonth&&inst._keyEvent)||(defaultDate= .getTime()=3D=3DprintDate.getTime()&&defaultDate.getTime()=3D=3DselectedD= ate.getTime())?" "+this._dayOverClass:"")+(unselectable?" = "+this._unselectableClass+" = ui-state-disabled":"")+(otherMonth&&!showOtherMonths?"":" = "+daySettings[1]+(printDate.getTime()>=3DcurrentDate.getTime()&&printDate= .getTime()<=3DendDate.getTime()?" = "+this._currentClass:"")+(printDate.getTime()=3D=3Dtoday.getTime()?" = ui-datepicker-today":""))+'"'+((!otherMonth||showOtherMonths)&&daySetting= s[2]?' title=3D"'+daySettings[2]+'"':"")+(unselectable?"":" = onclick=3D\"DP_jQuery.datepicker._selectDay('#"+inst.id+"',"+drawMonth+",= "+drawYear+', this);return = false;"')+">"+(otherMonth?(showOtherMonths?printDate.getDate():" "):= (unselectable?''+printDate.getDate()+"":'=3DcurrentDate.getTime()&&pr= intDate.getTime()<=3DendDate.getTime()?" ui-state-active":"")+'" = href=3D"#">'+printDate.getDate()+""))+"

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