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• • • GUil ti [lr'; )~tl't'i' WHO WILL REGULATE THE REGULATORS? If you make a mistake, shouldn't you own up? Not if you're the FDA, EPA, or FTC. PETER SAMUEL 0 N THE morning of December 13, 1991, teams of agenta rep- resenting the Food and Drug Administration (FDA) and the Envi- ronmFntal Protection Agency (EPA), accompanied by armed U,S. marehale, arrived unannounced at the 1•iockville, Maryland, offteAw of Sporicidin Inc, arid aimultaneously at its contract manufacturing iiacility in Joni:esborv, Tenneame. The agents seized prod- ucta, ordered a etop to eales and ahip- menta, and 6lod a formal complaint a]- leging the prnducts were "adulterated and misbrsuided." They demandcd that the company recall all its prod- ucts, and hegan searching and copying ita records. Sporicidin is une of several meusufac- turPrR of spore-killing products baaed on the chemical glut,araldehyde, which are used by hospitals, clinics, phyei• cians, and dentists for disinfecting seneitive. instrumenta and keeping tA- bles and other surfaces clear of germa, Until 1977 the dominant diainfectant was Cidex, a Johnson & JohnNnn prod- uct that is niainly compoacd of glu- taraldehyde. However, plain glutaral• dehyde hae several drawbacks: it is bulky to atore, for many uses it haa to be heated W work properly, and it gives off vapors that sting the eyes and nose and cauA-- skin rasheb. Robert Schattner, a dentiat in the Washington, D.C:., area, who had al- ready invented the well-t.rwwn throat spray Chlnraseptic, experimented with ways of overcoming these drawbacks, He mixed the glutaraldehyda with phonol, the main ingredient in Chlo- Afr, ~Satnuel runs t:r+rntrac.k Intarnarional, an enuironmtntol nawr asrvia. raseptic. The two turned out to have a synergistic effect, resulting in a disin- fectant that was able to kill germs, vi- ruses, and spores more quickly than plain glutaraldehyde, end that was much easier to uee. He started offering a line of productl+ for sale in the mid 19709, tuider the Sporicidin name. A number of product reviews in hospital jourttals found that the products had all the arivantagea that Dr. Schattner claimed, Others dieputed the matter, and there were various cldime and counterclaims. Some of these appear to have resulted. from honest differences of prr,feseional opinion; others appear to havo ~een mntivatod by competitive conaidera• tions. In any case, until last December the Sporicidin producta-a cold etoril- izing exflution, dieinftxt.ant sprays, dis- infectant towclottes, and a general disinfectant aolution-had been used unchangod since their introduction 14 years ago and had gained nearly a quarter of the S60-to-a7p-milLian an- nual market for medical-inatrument tli9lnfectants. Normally, regulatorx intervene when cuatomers are unhappy with a product, or are incapable of making in- formed decisions. Yet the uaere of Sporicidin and other, similar diainfec- tants are almost ezclusively well- informed profeeeionale, None of them had hrpn lodging complaints with the agencies. The Centers for Disease Control eays it does not have a recerd of any case of a disease acquired as a result of failure of Sporicidin. Ae late as December 12, 1991, a notarized let- f.er to Dr. Schattner from John H. Lee, the product manager of the Antimicrtr biel Programs Branch of the LPA's Of- 38 3ft NATIONAL REVIEW / NOVEMBER 2, 199(2 Gou of Pesticides and Toxic Sulr etanres, said Sporicidin was "properl-v registered and certified" and that it was approved for aale for the dieinfect- ing and sterili.zing usdn indicated ou itp label_ Hut the very next day, the agencies swung into action. The EPA has regu- lated such germicides for yeara; lately the FDA has gained a share of juria- diction, by defining the dieinfeictant solutions as "medical devicea." The Federal Trade Commission also got into the act by questioning the adver• tiainR claims made for che products. All three agencides iaHued long preel+ rQleases and gave press briefings aftor the raid. For the Prosecutinn 0 NE YH! TEXT for the raid wae 0 the claim that Sporicidirl did not have an FDA market- ing permit (called b10k). This was a Kafkaeaque comp)aint, since the FDA had not iaaued any rules aa to how companlea could obtain such cloar• ances. No clearancee at all had b+jen obtained by any company for any of these disinfectant products. A more serioua-IU,unding claim waft that Sporicidin producta wPrP ineffec• tive. FDA administrator David Kkwur ler wxa quoted in a press releasa- `These products do not work, Doctors, dentists, and other health profeaaion- ale ahould stop using them." The FDA also charged that Sporicidin products could cause "serious, adveree health consequences, or death." The EPA and FTC joined the FDA in publicly accusing the comPlany of false and misleading advertising, on the grounds that FDA lab testl3 had shown that the Sporicidin products faileti to sterilize as claimed. In the months following the F'DAJ EPA/F"I`C media circus, it transpired that what is ineffective and a menace to public health is not the Sporicidin producta but the guvernrnent teat. ln- deed, a year before i t participatPd in the raid, the F.PA formally acknowl• edged serious deficienciea in its teat. In a request for applicants for a con- tract to reaearch a replacemunt testing system, published in the Federal Reg- tster of December 6, 1990, the EPA said that the ensting test methods (the so-called AOAC aporicidal test) "lack reliability and reproducibility" and cited ten eerioua technical prob-

t • • • lems in the test. The ba.ic flaw in the current test in that it pits diain!'oc- tsnts being tested againet enormously varying numbers of eporea--aa few an a hundrpl in xi,mP cees, as many as a million in othera, And it is conducted in small containers of porroeiain with greatly varying nutnbers of tiny cracks and fiesurea in which the pathogene can hido from the disinfectant. tNor• man Miner, a veteran tester at Johnson & Johnson, said the test was so unreliable that all products, includ- ing his own company's Cidex, failed regularly.l 'I'he EPA subaequently awarded a f700,U00 research contract to a Canadian univergity to develop an improved taet. The FDA alao knew the test was flawed, as the July 13 noweletter of the Chemical Spocialtiea Manufactur• ere Aaacx:iation (CSMA) reporta, Vir- ginia Chamharlain, the~ person in charge of dieinfectiao etnd ateriLization at the FDA's offiee of compliance and surveillance, eclsnowledgea that the AOAC aporicidal test io "outdated" and says the FDA is working to im• prove ite test methode. Tim U7atowsid, asanciate director of the FDA'a Center for Devicce and Radiological Nealth, says. "AOAC methoda are troubte• some." Apparently, however, concern ebout the inadequacy of the tests at the working level of the FDA never fil- tered up to the elevet.d level of the agency's media-hungry wonderboy, David Kessler. Or perhaps he doesn't care? Day in Court S PpRICfI)tIN is not the only manufacturer heing haraesed. A competitor, Metrex Corporation, which markets MetriCide (a aimi• lar glutaraldchydc-baaed diainfect- ant), took the EPA ta court-and hu- miliated it. Judge Lewi® T. Babcock of the U.S. District Court in Colo- f rado concluded on June 18, in Metnex Corp, v. b6rilliam K Reilly (the EPA head), that the govern• ment had failed to follow proper laboratt>ry procedures in teating MotriCide, thus failing to prop- erly establish its cane that the products were ineffective. The case revealed various aloppy testing proceduree--over- diluted Ramples, ineppropriate documentation. In short, tha F,pA's teator, an FDA lab in Minneapulis, failed to adhere to the established code of Gcxud Labortitory Practices--the exact kind of negligent behavior for which it levies fines of hundreds of thoueanda of dollars againAt outside laboratories, Judge Babcock said that in his judg. ment the EPA's press releases and hot-line announcemente about the tedt failures of Metrex products were "as a u,ata.er of fact and of law false." He or- dered the EPA to cease ita ptatement.e and said that it "either knew or should have known that the results in this case were not sufficiently reliable to be called valid." The tests used to discredit Spnri- cidin were apparentdy juat aa bad. They were conduct2d in the aame food-texting laboratory run by the FDA in Minneapolis. The FDA teet data aheete indicate that the Spori• cidin tested may have been Allowed to age beyond the nabmmended limit, and may nlRo have baen diluted be- yond the level for which it is regia- tutvd. Even so, Sporicidin's cold atcril- izing solution paa8ed 239 out of 240 teata. Joseph Knnzelman, clinical director of oral-health research at the Walter Reed Army Medical Center, testified that his review of the tests on Spori- cidin persuaded him they were im- properly conducted, and said he re- garded the FDA report ae misleading. What of the dramatic I)ecember 13 charge that Sporicidin was "adulter- ated"? It turne out this allegation arotw from the regulators' innocence of basic chetniatry. They had noticed a discrepancy between the list of conetit- uente on the label and the nwnuPac- turing formula. Sodium phenate, which the product label names as a constituent, does not appear on factory invoicca. What they did not know was tn Yr. that sodium phenate is nbtained by mixing sodium hydroxide and phenol. Look!!!g-Ir14SS 1 c7gic F IVE MONTHS after the denun- j/• ciation of Sporicidin'a products, the FDA quiPtly signed an agreement with E3poricidin allowing several of the products which Admin- istrator Keaaler had said wero "inef- fective" and "adulterated" back on the market without any change whatever in their formulation, In the consent agreement between Sporicldin and the FDA, the company agreed to what the H'L)A chose to call a ',econditioning' of its product. "Re- conditioning" usually means that the product irs reworked to change its com- position and charactcriatica. In this caae, it refers solely to the inaertion of an extra instruction sheet in the pack- aginR. This misleading language ie part of the FDA'e coverup, an attempt to claim that the agency forced the company to correct deficiencies in its product, rather than admit that there wero no deficinnciee. Moreover, the FDA haa Also insidted thP company destroy rcprinta uf acien- tific•journal articles that touch on its products. FDA officem have demanded to supervise the dumping of boxoe full of articles on gluttrraldehyde•based distnfectmnta publiahed in The Journnl of dpernting Hoom 1teAearch, The Journbl of Clinical Micmbiology, and auchlike. At the time uf writing the EPA ia still holding out on Sporicidin with some bizarre maneuvers of its own, ot- fering to lift its freezP on Sporicidin's cold sterilizing solution-which the EPA had repeatedly approved before December 13---only if Sporicidin does its own laboratory teating to dcmon- strate the product's efficacy. So we have reached the eituation --~ whore the FDA has allowed prod- neutralizing rwlutions, failure to "You'm use control aamplta--and poor big trouble, fella--you ie trespa.eaueg on u/JYcial gouerntnerst wetland" 4.0 NATIUNA(. REVIEW / NOVEMSF.k 2. 1992 ucts back on the marktt which David Kessler naid last year "don't work." The old AOAC test is diacredited, and therc is no generally accepted teet to dem• onatrate spore-killing power. The EYA, as we have seen, already haa research contractm out with a Canadian company for an im- proved lest, but now it wants a small private company to pasa a completely new battery of teata laAting many rnunth® while its

0 • • • products remain banned on the baaie of tht diecrcditod test. Only in Amorica. SporScidin est{matea itu ltsses to the end of July at more than $10 million- $5 million in lost sales, $2 million in customer reimbursemente, $1 million in legal fees, and $2 million in lost in- ventory. Thirty people in the manu.fuc- turing plant lost their jobs, and a dozen administrative and ealea people have gono. In their place, a team of ltlwytrM. Agencies that are Qnppoaedly dedi- cated to serving public health aro en- dangering it by spreading disinforma- tion, disrupting the supply chain for diainfectanta, and heavily aeaaulting the economic viabi2ity of the aompa• niee that manutacture them. Two of these have been farced clcm. to bank- ruptcy for no good rea8on. Another, 3M, has withdrawn from the market. opting "not to get bogged down in the Federal Government'e regulatory proc- eas." The regulator8 are adding a mas- sive riak premium te the calculations uf anyone doing business in territory where the government gangs roam. What i® behind this destructive madness? Several agencies fighting for regulatory turf? A drive by regulatorn to jutiify their budget claims in Con- .\u Si,,;;lc' I~~rtc• gteea? Nursn$1 Waahington hlunder- ing? Perhaps a bit of all of these. O THE ABORTION WAR The paradox: Most Americans are 'pro-choice'- and yet they oppose most of the abortions pcrformed. MARK Ci1NNIM6KAA1 T HE PRO-LIFE movement is on the ropes. The Supreme Court has affirmed the central tenets of Roe v. Wade and embraced the cnn. cept of radical individualism that is at the center of the pro-choice poaition. President Bush, who has held the line on abortion even though he cannot present a coherent defense of hiy view, is likely to be replaced by Governor Mr. Cutminghunc ia NR's Articlea Edaor. Clinton, whose Administration will surely emhrace l4nlation tu roll beck the modest restrictions the Gourt al- lnwed in f'lanned Parenthood v. Casey. Are there any anneta remaining to thoae who resist the transformation of abortion into a positive good? What atrategiea ought they to follow? First of all, there is considerable re- sietance to the actual practice of abor- tion. Though the AMA abandonod for- mal opposition decades ago, abortion is nonetheless fenced off within the medical community. At U.S. medical sehoolt, only a quarter of ohlgym reai- dency programs require abortion training, and another quarter dnn't offer it all; participation in the op- tional programs is low. (How many mothers dream of someday preaenting "my son the abortionist"?) In 1990, according to the Waahingwn t'cusr!, "roughly eight thnusand 1R,OQ0?j phya- iciene performed mnat of the 1.6 mil- lion abortions in the United States . Roughly 70 per cent of those abor- tions are performed at 300 clinics." Outpatient clinics performed 4,6 per cent of abortions in 1973, 86 per cent in 19R8. The atAndards vary from the relativety posh and professional Rerv- icea of Planned Parenthood to what are quita fairly cAllFSd "abortion milla," places even the n,unt z,ea.loua pro- ehoicero are ashamed to defend. Activist pro-choicers are up in arms over the fact that B3 per cent of the 3,135 Counties in the U.S. have no fa- cilitiee for abortion. The numberu are deceptive, since the more populous eountiee are full of clinics, and it is no great burden for moat people to reach the neareat good-sized city. Still, this auggeatA that community sentiment ~ -- Th£} :ay we are "drifting." s:F41-- .- , -,,= Th'.i~'~fay we "lack a cause" I txi:ine meet a few ttiand who disagree. M MEN 0 rican Collegians for Life f.! Training Conference nnual National Leadership 2-24, 1993 • Washington, DC A~a ff'Cbnference- f3ux 1840, Fairfield Univ. 0! [;•CT 064:1p - Or Call Z03-?54-y1 U3 Mm 42 NATIf.)NAL N.EViE,W ; TlUVEMAER 2, 1992