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wa11 St. Joutrnal Vew York, VY • • JUN 2 4 199.i FDA Red r['ape Dooais '!'ratisplaiit Drug By LPIN tan (;. Wn SuN Antilymphocytr glnhnliu tAf,(;I, a drug used to suppress thr immnur sy:atrm io kidney transplnnl pnlirlds, hlls had a ~ing'~. r~triqRnnw» ul~u lllr survivaj raTs ofTN tir}+uti.tvus nnd Irans planteii organs. 'I'hr Ihlivr-rsit-v-uf Mlu nesola developed AL.(; Iu ils own hihs in 1970 and had been selling it fur 22 yr more titan 150 trauspllu rtef`s through out t ,,mada. Ihd for nrariy a year, because of mi.aRuidMl FrNel anlt Drug Administt,uion artintl, Illr saiP aud use of the drug has hPrn SnSIIrII/IPIt. In continldng Io drrm ALc7 Prperi• mental and then susftruding its distritnr tion on the gro(mds of "viulatinns" nf at tendant recordkeeping rltlrs and the like, the FDA may claim thal it drMs nat know AfMMye safe and effective. Bat in making that clailn 1t declares its will. ftll ignorance of thr medical and srirn• tific literature, aud its runlempt fnr thP community of transplant surgeons and their collective re/varle/f experience with ALG. fM igttoranre and rnntrtnpt prnvidr a sound basis fur a inrlh.(• hdrnriwi lo pl u tect the public? Despite its widrsplr'rnd clinical nsr for neeriy a quarter rrnllnv, rlrspilr Ihe rr• suits of a doublr hliud ('onuulled stlnty published hl 1985 shuwing ALc; In Ire safe and effective, nud rirspile Ihe dramallc success at many mediral crnters with the sr•quentIal use of ALC and another dntg, ('yc•hsixnine A. -V.cT Iln. Irnlniurrl. in thr eyes of the FiIA. r'vprl inu'nlai As au rx perimental dnlg, the FDA has rMplirrd Af.G to be sold at rrr5tt mtd it alsn has ce• quired detailed rrcnrds tu he suhmltted for each patient to whom Ihe drug is given. And even mure hizarre: the FDA's demand that ttlr IInivrrsitv of Minnesota erect a large buiiding. snid to rnst $13 tnil- lion, so that ihP druL, rrndrl F,r "prnperlv" manufacture/l. When the drnsmrl fm At,(; Irrsr lu nn expected levels. hrcausr rd fhr rPlnalk ahle success after H)R5 lit nndliple drng therapy, the ALt; plrlgrnm lrgnn to hring in large revenurs. Whrthrr a prlrtinn lit those revenues werr prnfits ar nnt rr• mains uncertaitt. Rut whal srrws cleat is that the ennrmrnls growth lit drmnnd for ALG overwhelmrrl the uuivrrsily's capar- Ily to do the requisilr arrnunting for Ihr FI)A and to 715SrnIIIIP ancl lulaivze fhr records of p,tlients rrrrivinK AL(;. The histnry nf Illr rtfrn ts of IIIP I Inivrr• sity of htinnesnL'I trt nhtltin FI)A approval of ALG Is nhsrulr. Aithnugh rllief nf surgery.luhn Najv imt appliect fnr permis sion to test AL(: fn 1970 an(I the ltrpml- mettt uf Slu'grry hrglm lu srll AL(; tn other medical (•rnlrrs in 1971, 1)r. Nalal' ian did not furmltlty apply tu lhr FI IA ful approval of Ai,t; unlii 1999. Nevrrthelrss, according to n l'Inrn11110k+y pIlI11iSIIP(I last November in thr f,)innrafndis Sl•tr'11i hune, the FIIA tenc nwtllr in 1975. In79. 1985, t!187 anli 089 that Ille uuivrrsily was srlihl{; ALti. Iu SeplemilPr 1988, at Ihe rr qurst uf Ihr FDA, lltr nuivrlsity stopprrl tltr sale of Ihe drug; it distributrd it flrr of rhnlgr nnlil May 089, wh6u the Ff)A Invrvl its sale In rlrn'lurs cYludurlinq fnn tl trsls, hrn Ihr FIIA gave Ihr Iuliversily prnuicsion to sell fIIP ch'ng tn rr srarchrrs, It requirat that the prire lte Irducrll from s2351o S131 a gram - a price thr F!)A brlievrd rrptrscntrcf its h'ur pr(Kiurlion cost. Hnw lite Ff)A arrivrd at tids peice is unknown. In lune 19921%be; fure pneluctiun of ALCI could he started lit lhe E13 million FUA•maudnted huit4- inR, FI)A InspPlturs vlsilyd lllr farfilly aurl frnnl4 the ALt; prnRltnn iu vinLttion uf still nlnre FfIA rulrs: (nle shipwent rlf tile druRs had raps that failed. It minor prubirut quirkiy rorlrcted, and the pm gram wns hrhind lit its recordkeeping. On Aug. 13, tlle Fl)A halted the salr and usr nf ALt; tmtil these "viulati/nts" wrre rrmcrlcrl. Tite sale and use trf Af.(; Irmnius susprude(I, an art that has al- Irnd)• drplived hundrelk of palients of AL(; aucl Ilutitwn tnore than 35 people (Nd nf wulk. 'I'hr Imivetsity arknowtetlRrs that It fallPd In do all nf the an(nrNls papelwul k Irynirrd for the approval nf AI,U ami thal, hryplrnlly, letters from lile FI)A wrnt unausterrrcl. The FDA, tltereforr, hlui leasun tn lie irritated. But did the Ff)A's anger at the University of Minnesota jus• tify banning the sale and use of a drug that has proved safe, effective and ez• t"rnu9t , •Ihadbb, in Ihr Iw,lim"ml ~d Ih"m ~,Ind', -d u;lu,pl:lnl patirulx arr mmr Ih,lll 2n Vr,11's7 'I'lIP ariinn uf thr Fa)A nwst I>rjudged hy its resnits. It has taken away from trans- plaut patieuls an essential component of the uwltiple dnlg therapy with the highest rates of patient and organ survival. It is couceivable lhat patients may die hecausr Af,c, cannot he made available to thrm. 'rhr rnntrnst hrtwrrn fllr I IIA's vigi I,tur r rln AL,( i nnd its arlirms lit IrIaliuil tn rdlu'I innnunr snpplrssaul dtuks is stt ik inK. In 194:, /lrlhn i'hlnlullrrnliral Co. in• IrrMlnrrli a nrw drng rnlird UIC'1"l, in Irnrirrl trtnvrrt•nuu'suutruf lho limilatintls nf ALcL Inilialiv, UK'I'4 was nsrll tn trr71 nulv sovrrr rpisxlrs nf kidnrv I rjrrlinu. II plnvirlrcl tllr sruue Ilrgrce of ilnlulnlr snp plrssirm as At,/i anll there wits nn AlRltlli rant tiiffrrrnrr itelwrrn Iln` Iw'rl rit'uQs in tllr slnvival ralrs fur eilher pntirnts ul iln plalurd nlg,lns. IIu111K'l'1 patiruts did suf frr lurnr ftrrluenl SiQr rffrrts, inrlurling fPver, hrralldrssnoss nnd arule respira• Inl'y' lllstresS. Ancl IIIr ttvo rlluRs diffrred siRnificnully in rost; A five millitlrun dneP nf ()K'i'.'i tvns xI1H1, whrlrns nwIr alrtnl drl.r of AI,I; was rmlv S131. I'hr FItA ;tpplnvrri IIK'1':1 6n f;onrlnl usr in 19A,. aflrl nuly funt vr;ns uf riini (.al IrstinK. Yet itl 19'.)n, t l Illo rll:nm rrf tr sratrhrls. ,I niurfold iurlr,lsr in Illr inri rirnrr nf lylnphmnlt wos rlisrnvrlrrt Innrm(; plltirnls Irr;llrrl wilh nf('I"t. Whih" Illr FItA rnntinnes to approvP QKT3 for Krnrrnl nsr. it denies approvai for ALG. t IKT3 is nul an isolated case. Azathio• prfnr, ('y'rtnsprmine A and ATGAM were nisrl tqlprovrd hy Iite FDA after trials on tolativrly small munhers of patients ex• trnrlhlg ovrr rrlalively short periods of lime. All flnlr autirPJPCtion dnlgs are pro- durr4 hy pharmarrutical companies, whirh possl'ss staffers who can devote their ttdl tilne to ensure that the detailed infurumlinn rrquired for drug approval Is provided prnmptly to the FDA. Once ap• pruvnl has been granted, the FDA be- conles remarkably tolerant of any short• cmuhtgs in a drng that may emerge from fmihrr rrpPrlrnre. Ity and large Ihe agenry should be tot• rranl. Any drug that is powerful enough tu lie Pffective for nne purpose Is almost hcauni to have nndesirable side effects. Rut IhP FDA approval process has become ;ut rxrrrisr of legal power, not a dectara• tiurn of srirnlific knowledge. In its decl- sinn to han thr sale and use of ALG, the FI)A usell its power irresponsibly and withrmt rrQnrll inihe needs of patients. (h•. Ililsnn is rhninrran of the histoty of ulrvfirirrr drlwnlmrnt nt the Unitrrxitv of alirnrrcrdrr rur+lirvrl srlrnrrl. 0