Woman participating in Lilly trial hangs self’ Coroner will consid whether experimental ced possible part arold’s suicide. By JK. Wall and John Tuohy "A toxicology test will determine whether narcotics played arole in the Suicide of 19-year-old woman who ‘was participating in clinical trials fora ‘new drug that El Lilly and Co. hopes to launch this yer. ‘Tract Johnson, Bensalem, Pa hanged herself Saturday night in the Lilly Laboratory for Clinical Research by fying a scarf to a bathroom shower rod according tothe Indianapolis Po- lice Department ‘While the toxicology test is stand ard procedure in the vestigation of Stieldes by the Marion County coro- ‘et, it could have huge implications for Lily fi i determined that the trial drug — or removal ftom it = played 2 role ia the woman's suicide. Tilly said Monday it does not be lieve the drug, duloxetine, was related to the death of Johnson, who was a former student at Indiana Bible Col- lege. But Johnson's family and fiends Said it was inconceivable that the bub- bly and generous teenager would have Filled herself "Toxicology test results are ex pected in about a month. Dalotetine is key to future business prospects of Lilly Is the main ingre- tient in Cymbalta, an anti-depressant drug and in a stress urinary incoat ‘pence treatment, both of which ase moving toward final approval by the US. Food and Drug Administration. However incidents suchas the sul- cide ofa clinical tal participant often ‘draw questions from the FDA and can ‘delay the federal approval neded 10 bring a drug to market. Inearier statement, Lilly has said iexpects the FDA to approve dulose- tine to treat both depression and in- ‘continence in. 2008 Analysts. have predicted sales of exch could near $200 milion this yea. They bill Cy iat 25-2 potential blockbuster that could top $2 billion in sles by 2008, ‘Seo tity, Page B6 ‘No column today Columnist Ruth Holaday has the day of Her column wl r= {urn Thursday. OTLilly 1m Death will not halt clinical trial, company says. From B1 ‘Smith sad, she was on a placebo. "Based upon ovr initial review, ‘we donot believe at this time that the design or conduct ofthe study js related to the death,” Smith sid, He said Lilly would continue Tooking into the matter but added {hat at this time “there's nothing tosuggest that this is anything but an isolated incident.” "Todd Lappin, the Indianapolis ‘defective who investigated Johnson's death, said she did not Teave a note, making her motive tunclear, “I talked to ber fiends ‘They all said, ‘She was chipper; Lappin said. ‘When asked whether he thought duloxetine contributed to | Johnson's death, her pastor, Joe! | Barnaby, sad, “Abolsutely. This 1 | atestng drug ... This gilis nota i irl that had any type of suicidal Feation. She is a bubbly person with a postive personality” ‘A nurse found Johnson's body around 820 pam. Saturday at the Tilly Lab, whieh occupies the fith and siath floors of an outpatient ‘enter on the campus of the Ind- ‘ana University Medical School. Lilly's clinical tial is one that tests "healthy volunteers," who do hot have depression or incont- hence, in order to evaluate how the human body metabolizes the ‘drug and to examine proper dos- ‘ages and side effects. ‘The FDA had requested that | itly“conduct this latest safety test, even though duloxetine has been tested on more than 9,000 people to date, Smith said. He fbdded that the FDA had not asked forthe study for any suicide risk. FDA officals could not be reached by phone late Monday. Johnson joined the til in early January, staying overnight at the clinic, but with the freedom to ome and go. She received $150 a ‘dey plus meals — money that relatives said she planned to uge toreturn to college ‘Smith sad there were about 25 PORBTRRRE SVE local volunteers participating in the tial and about 75 more across the country. Nohnson's mother, reached by phone Monday night, declined 10 etquoted for this story. Smith said that Lily informed Johnsoa'sfami- Iy of er death over the weekend. “tesa real tragedy. We really feel sorry” Smith said. “We ex- tend our deepest condolences to her family. Tilly wil not halt its clinial tril of duloxetine, Smith sad, be- aque th company dows 24 Be Tieve the drug is putting partici. pants in danger But Lilly did Conduct additional monitoring of the other participants ater John- son's deat ‘Smith sai Lilly would make a formal report to the FDA and imilar ‘international. regulatory agencies later this week. Similar incidents have sparked lavwsuts against some companies, according to two clinical tral ex: perts at the University of South- fem California. And those lawsuits ‘Sometimes have led companies to ‘suspend their clinical trials, said Peter Pressman, clinical physician at the Keck School of Medicine, land Roger Clemens, professor of molecular toxicology at the School of Pharmacy. ‘But both Pressman and Clem- lens noted the regulatory protocol for the safety tests in whieh John- son was involved requires an abundance of safeguards stand- ardized by an international or- Eaton iy screens participants atthe Lilly Labs with physical and men- tal exams In safety tests, the com- any also must make sue that participants do not have t fase oF condition that is treated by the drug being tested. Partici- ‘pants must sign consent forms af fer receiving explanations of a ‘drug's potential side effects and risks in both technical and lay- ‘man's terms. “it's more careful, i's more thoughtful — almost fo a fault — than most people, realize.” Press: ‘man said. ‘usta epater Tom spading entroutea to Os sry. (al tar reporter 1X. Wal stam aes sc ESSNOversight panel orders changes in Lilly trials By J.K. Wall and John Tuohy jkswall@indystar.com Eli Lilly and Co. has been ordered to stop accept- ing new participants for local clinical trials of an anti- depressant and incontinence drug following the weekend suicide of a teenage test subject. ‘The Institutional Review Board that oversees all Lilly trials on the Indiana University medical school campus also decided Tuesday that the company must bring in an independent psychiatrist to evaluate par- ticipants. The company also must ask them to sign a new consent form to continue with the trials. Lilly reported to the board Monday that Traci Johnson, 19, a former student of the Indiana Bible College, hanged herself Saturday in the bathroom of her room at the hotel-like Lilly Laboratory for Clini- cal Research. The Rev. Paul Mooney, president of the college, said many students at his school and other nearby universities take part in the clinical trials as a way to earn money and pay tuition. See Lilly, Page AT?Lilly _ us he si “We ake a report ot a se very seiosly™ The a will srwne Lys epors —— ad prhape ask for more tr te pokesman says teen was screened for depression. From At Seley Bis, admlisator in charge ofthe fie institiona ce ‘Tewboards tat oreac esearch THTUPUL expressed dismay at tbe Satori ang rom, ce al peop and many of shave cifen and we woul be Utressed By that happening tO {ee ea ls ay a oetng omits dro duonetine. “The compound as been 00 ing tard nal approval bY the ‘GS ood and Dro Admins on to rest both depression and Stes urinary incontinence Data om the cla! tals would be ‘Shean or bth uses. Ty ofc ave told Wall syret analysts they expect to fntnch the depression drug ths fammer and the iocotnence faetiestion Ltr this year. Ans fps have pedicted that sls of ‘Ye incondaence dug could ex feed $1 billon and tat the de pression drug called Cymbal oul top $2 tion. hase, a naive of Bensalem, al ts one of aboot 25 ealny omer serving a8 tet ab joe for dalorene ot higher {Eap-normal doses She had Beso opsicaly and peyeolopcally EEened before tbe test and id pot bave depression, Sth sid “The FDA had requested (hit uly couluct the safery test, ‘ytch pialy examine side eas, iy sill has several days t0 submit aeport of he nee 10 ‘Re FDA. wilh wil hen oo to the mater FDA spokesman Jason Brody site agency coal ot comment specially 00 the Sb fouetine ies. ‘mation sch at pent records Ed put rl data be sa “tf efnely requires some n- vertgnton” std Set Henry. 2 ‘Noo analy covering ily at nbeimar & Con Boston neicsineor ewe Siloneine — ote ffomit~ isnot spcicly tikes to jehnson'y death Seo ys not 3 8 wel ing 132 to Seeagase "The Marion County coroners office ae ordved 2 (OcOlogy {Sto determine wheter dupe ‘layed aol in oso’ ue yin preliniary review, conced tha donee dil not ‘hive er deat Johan ine the iin extly Saary She nialy Bad eet {Gres dloresne but at the tine ‘hing ‘es being om the dr or Being ‘thd would pose a suse ‘sk smith a ounon's ator and relatives, however have boty countered Scone. Tey sted oh Seats active patlpaton in bee ‘Sure, Geser Church of Pil ‘Sign, where se led 2 Tey heat youth group and some ing {Bg dang woah services Her { = Doing Quality Work for Over 43 Years “From Complete Bathroom >) Remodeling To Shower Wall Just Onp Gall - We Oo RAM) Toll Free 1-000-430-0960 F beacon © fe | Ps Se 1494 Madison Ave, At Stop 10 Rd. eTADTC TONAV' From Page One cide they a was totally ot ‘chars ‘Strat hnaon was on of he sa young Bewie of out (poops Her death has ake SEP out of ur church fal ‘Sidhe pastor Jol "ers Shara, president of the ‘lance for Human. esearch Protection, sid people of Joho Sots age often are, go mare Sought grasp he ks of Sue ca “She jut finished Chie) school Share suid. "Where is tbe culo ‘uth sd Lill cuof i the leg age of “Theyre cetsily (Sesdered aus be sald Mooney aid his cal ne ‘er coioree nor scourge: ‘deat prtipaton in the std “we have nothing to do with Lily wbatsowree” Moogey Sid ve dou recat for them, and “They dont “He sad students ave de. eloped pipeline to Ll: Most Iroek to pay tek tution about ‘S000 yea ans Bible College i four yearellege sponsored by Calvary idermcle 000 § atcher Ae ‘The church ie an Apostle Pen (eros churehafliated with ‘Gated pemeconal Internationa "Abou 70 pera! of the cl sage geo students are from out of ‘te Ty attend to preparer Replacement.” eer) nnn te tm | \ ‘oa death hard, Mooney a ‘Sunday morning, Dy. Michiel “Turek milly spoke tote st Enea te Calry Tbemacle Shap | ‘Mooney std he. ha, spoken with Jobs's family and wl a ood ‘the fneral Tours in Pennsylvania Presmanic Ashraf, 19 te aden are not ready 10 ‘lime Jobs's sucde om the ‘nial sae Wie al fave an open mind about this, special since there fees may people ere who do the tie? be sai 4Days Oni Feidey + Sturdy Sondly | monday Feb 12, 10-65 Feb 14, 10-6pm Feb 15, 12-5pm Feb 16, 10-99m 7 ALL STORES OPEN EARLY §d reform plan. 66 By JX. Wall Roalsingystaccom li Lilly and Co. said Wednes- day that nearly one-fith of the participants in a clinical tial fo Rs new anti-depression and anti- Incontinence drug have dropped cut ofthe study after one test sub ject committed suicide over the ‘weekend, "At the same time, Lilly ac- nowledged that four other sui- cides have occurred during sev- tral years of clinical tals on the ‘rug duloxetine. However, the other suicides were among patients with depres Son, unlike Traci Johnson, who hhanged herself Saturday ‘while participating in a trial involving ‘hat Lilly described as “healthy” volunteers "That difference bas led anti depressant watchdogs ffom Sround the country to seizé on Johnson's death, saying the facts point to the drug as a possible Enuse. But Lily officals reiterated Wednesday that they do not be- lieve duloretine played part in Death allout in drug trial 20% of patients exit Lilly's study for duloxetine after girl’s suicid “Thursday, February 12,2008 Section G fuels as “healthy” , ‘volunteers. the suicide and that duloxetine bass been proven safe to treat pa nts with depression. isa sad fact isa tragic fact, that. sometimes, these patients ‘commit suicide," Lilly spokesman Rob Smith said, "The. rate of suicide for de- pressed patents taking duloxe- Eine is lower than for those taking 1 placebo. Ie’ also lower than the ‘ake for an older group of anti- epressants known as SSRIs, Or Selective serotonin reuptake in- hhibitors, Drugs such a8 Prozac, ‘Paxil and Zoloft are SSRIs. ‘Of the 442 depressed patients ‘wh participated in Lilly's duloxe- Soe Dru, Page 67Drug =o At time of death, girl had been on placebo for 4 days. From 61 tine studies, 0.097 percent com- ‘mitted suicide. The rate for SSRIs is 15 percent, according to num- bers cited by British drug regula- tors. "Those facts didn’t stop three participants in the study in Indi fnapolis and one whole center in Evansville — which was studying 16 people — from quitting the study, Smith said the 19 depar- tures dropped the population in Lilly's study from about 100 to about 80. "We clearly anticipated that a ‘number of patients would not continue the study” Smith said, ‘adding that the company would still have enough participants to complete the study enrolling any new participants {ts duloxetine study in Indianapo- lis. at the Lilly Laboratory, for Clinical Research on the Indiana University Medical Center cam- pus ‘The order was issued by the Institutional Review Board, ‘which oversees all Lilly research fon the campus. Johnson, 19, was one of about 25 healthy volunteers in the Io- dianapolis study. Lilly said those volunteers did not have depres- sion and were participating in a study testing the effects of higher than normal doses of du- loxetine. Johnson reportedly hanged herself using a scarf tied to a shower rod in her bathroom at the hotel-like Lilly Lab. ‘Her death came to light the week after an advisory commit: tee to the Food and Drug Ad- ‘ministration recommended that the regulatory body discourage the prescription of antidepres- ‘sants for children under 18 be- ‘cause of an increased risk in sui- cide. ‘In December, Great Britain's version of the FDA told doctors to stop prescribing antidepres- sants to patients under 18 after it concluded that the drugs caused suicide rates two to three times the rate for patients con placebo. ‘Dr. Joe Glenmullen, a clinical instructor of psychiatry at Har- yard Medical School, said ‘Wednesday that Johnson's lack of depression, her young age, and the time she had been off the ‘drug suggests she was vulnerable to suicidal thoughts. “She's still a teenager,” Glen- sullen said of Johnson. “It does Took that children or adolescents ‘might be even more vulnerable to (Guicidal thoughts while taking antidepressants) Glenmullen, who wrote book in 2000 attacking another Lilly antidepressant, Prozacy said that the rate at which du- Toxetine breaks down in the body is similar to the rate for Paxil and Effexor, which in 2003 ‘were the subject of "Dear Doc tor" letters issued by their re- spective makers, GlaxoSmith- Kline and Wyeth. The letters ‘warned of the increased risk of suicide in teens. Paxil, Effexor and a third drug, Zoloft, all have high rates of with- ‘drawal symptoms, between 60 percent and 70 percent, which Ean also include suicide. Glen- ‘mullen said patients taking anti- Sepressants are most vulnerable to suicidal thoughts three to 10 days after they cease the medica- tion. "At the time of her death, John- son had been on placebo for four days. “It could tmave been a dou- ble whammy, really, ifshe had be- ‘came suicidal when she was on the drug, and then came off of it,” Glenmullen said. Johnson's trial was a “high- dose” variety, Smith said, From the time Johnson began the trial in early January, her dosages ‘were increased gradually t0 a peak, then gradually reduced un- til she was given placebo. “She was weaned off the drug,” ‘Smith said. "The FDA has asked for such high-dosage tests recently to test whether patients have difficulty metabolizing antidepressants ‘eal Star reporter JX. Wall GU) 4446287| FRIDAY, FEBRUARY 15,2004 | Sever rwararce NDYSTAB.COM “Traci made a tremendous impact on us in such a short ime, ‘and it takes a lot of personality to do that. A SPIRITED FAREWELL @ a wrdax rears cary te con fal oon ot of te Padi hurch hese Sa a i ls i cme sary 2 aso Mourners recall teen’s smile, optimism | many wii, wn peut! ip Me | ci ie sig ‘Srcowechoitjohnsonnce sang withhod’ “Any 19-year-old who's [Farewell S305 S5% secu an or iar Toward the celine The Spay amas fork TT anes roeerae [eager ee eee, i inner-city youths. ‘stood open at the foot of the alta. ‘out on the street doesn’t From at exe fet om the foot und tke a loner” fy) decisions about the future would” More than 300 mourpers ied fecsions une they had prop- the church on a sieet| wher® Lee Godan aro va ace ugurer Johnson, her mother and otber Grater Piacelpa Church Yew ret and Ge-ic members regularly tested theit are Tch by to young fh agaist some ofthe i's homeless man was walking deeply sen Oy ese mag, routhest conditions. The day be- said Tiffany Wilson, one of he | ott griefbeing experienced by fore the funeral, Barnaby pointed teenagers, at the flea market, Ine the ef bing ere cut places where shootings drug “Everybody. moved sway “when herloved ons hice fo them" deals and ther ces occured, they Saw im” because of bis tes ment Thursday. “Welcome toe neigboriood frightening appearance ly sadn er Barnaby that Tach Towed” Barnaby said One of the man's fect appeared said. Johnson's mother, ‘Thursday. "Vstors we hate our tobe grosly infected and swollen sad Johnsons Tomoling Si ushers alert outside fo keep to thre times is normal size, He Jabnrerhone conversations with You ies on your ears" tras hobbling and asked for help im elephone consetTapncce ‘cnr Earlyon Wednesday mornings, with his shoe. A the other teens feted the drug ta armuby ol the crowd, Johngon backed away, Wilson sad, Joho | feted toe would call and wouldoinother church members 00 stepped forward, ot down on ser RRELSASING Rinuyor felon was through the neighbor. one knee and adlusted the shoe so FER MTREMFpeley ised hood, olen encountering steet the man walk more easy. fanny ray PERE SSoeerer people, drug dealers and pros “Trae just had such great chat- ‘fone a being real sly and ight> fates acter and pnt” Wilson sid headed "Ata particulary rough comet, “she has been an inspiration and Ade ily didnt think any--Johnsoa would sometimes cry a8 taught me so much. Fen a enc meray She prayed, "Gov, save this ig Frlends col the congrezaion _} | ine of 2 Stow i tet borfoad, heal the broken lives that Johnson enrolled af Tadiana Sa omar lefts that are ete te pastor calle, Bible College in ndianapls ast ‘tom the test. “Soc day she er some fiends fll with the hope of eventually re- 2 Ae parged with up- worked at» Sidewalk lea market turning to the neighborhood. sesh Fane ck rom the torase money forthe church."A The Rex. Paul Mooney, the stools president, said Johnson made frends quiciy. For ber fv feta he and 1 students from the allege drove to Philadelphia. ‘track made a erendous in pect on us i such 2 shoe time, Todt takes alot of personality t Af that he tld the crowd, Her father wat between jobs, and Johnson tok this semester fo jo the Ll rug program So she could earn enough for the | $0 nua ration. She was psd 150 2 day, plus meals aod NOW thru MONDAY yea Ae 2nd pair [oa - From Page One THE INDIANAPOLIS STAR - WWWINDYSTAR.COM sai John Crompton end rom Phelps whom sbe once he ‘a ‘raking after the service sail"Se ogi twas te bt ‘Bing tw do, etme that was the Say tat sb a one tbe He ose ot hee ‘Gromioss who atended the Inanapls schoo! fr a whe ‘ei ad le to ery tele Fone the night before she died Eaten ah te flowing 5 fit hour before hor body at Toiod She sounded happy She was 2 prety peat person Bren hen ine weerowgh he would beep ace euod spi abou nes uae wes eager fo come sal and workin te common Sure ta er th could elp ‘Rake ‘a iflerece, fiends sd teen a oe of soe ‘els who sd ots was 00 Kopel to ave hanged ere (Gin an soca pastor tthe Shor otters as chap {air the Pot Cegy uit the Pilatlpia Poce Depa ten sd he ha aed th ounclng at sree ater ‘Sides epi who ty to el theseler be ores, pily five few contacts nthe com. ‘etn do not communes well Ind ae oberwine alate Sine! athe onze of hag be su “She rs ey folved sor oly wher oly rho cre nda pole and Palade Any 9 Paroles ig Yat in te moming to eo Pray futon the sreet does sound ihe ner Sh bad age ture ahead ters he sai She, wat bling (erward very much to coming [cree to work with iaercty you al Sipe nm Seuss SaatiDrug trial participant recruiting questioned Suicide of 19 year-old in Lilly study puts use of college students for tests under scrutiny. JX, barb Bregntz Seton "A age 0, Bean Eas sav « tu led buen toard on (he TUPUL campus tasked fr ‘ohuters to blp sty the eet ee Eee roche! eee — 1 1] undergoing Seon say ected “would do another" said Bran nig ow 25 Abd infact the ‘me uly was potted prom ‘ently let weak a Indiana Us ‘ery Purdue Universi nda trees le you cx look Paty bolle board, and there ‘Tile atleast one af hove fers wie 'Saoting in at research sub- jects commoaplace for students over and oer maor te earch universes fom Teas Wircona ‘Aitvough no one knows, ow many cllege tent fer tem ‘elves a ine is they ae x ‘owed almost duly to notices or Bie thoueands of ‘ongoing re Search projec ia eal eb Site flrs and word of mouth "Fiat word owes echoes (0 smaller schools ear 4 research echoing students oakRecruiting = TESUneS Wataer bce sural ecole Cn wa, See eae ee Shahi: Sneior mea, sean us ii il ul i i ti a cit 5 a8e i Bi a : th eH rit GEL i au EF i