HEALTH - Drugs Online: Virus or Cure?

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June 12, 1999, 8 a.m.

It was a Sunday morn­ing and Den­nis P. Fitz­gib­bons was check­ing his e-mail at home. A few days earli­er, Fitz­gib­bons’ boss, House Com­merce Com­mit­tee rank­ing Demo­crat, John D. Din­gell of Michigan, had asked the Gen­er­al Ac­count­ing Of­fice to con­duct a study of the in­creas­ing avail­ab­il­ity of pre­scrip­tion drugs over the In­ter­net.

So there Fitz­gib­bons was, scan­ning his e-mail, only to find two mes­sages ad­vert­ising a Web site where any­one could pur­chase the anti-im­pot­ence drug Via­gra without both­er­ing to see a doc­tor. As he clicked through the site, Fitz­gib­bons was hammered with dis­claim­ers and li­ab­il­ity re­leases such as: ”I un­der­stand the side ef­fects of this drug … ” and ”I cer­ti­fy that I will an­swer all ques­tions truth­fully.” Yet nowhere did the Web site dis­close Via­gra’s pos­sible side ef­fects—in­deed, the only real warn­ing is a sug­ges­tion that the con­sumer an­swer ques­tions truth­fully be­cause ”your med­ic­al his­tory in­forms us of any pos­sible med­ic­al con­train­dic­a­tions.”

Fi­nally he was promp­ted to give his name, phone num­ber, and cred­it card num­ber. And though Fitz­gib­bons was told by the Web site that a doc­tor would re­view his ques­tion­naire, the end of the ap­plic­a­tion noted that pro­cessing ”may take up to two minutes.” And, in­deed, with­in a couple of minutes, Fitz­gib­bons re­ceived an OK. Though he didn’t or­der the pills, he was dis­turbed at how eas­ily he could have. ”It was a Sunday morn­ing—I’d be very sur­prised if there was a phys­i­cian sit­ting there” re­view­ing his ap­plic­a­tion, he said. ”It seemed to sug­gest to me that your vir­tu­al phys­i­cian is a vir­tu­al quack.”

Fitz­gib­bons’ ex­per­i­ence un­der­lines the fact that it is get­ting easi­er and easi­er for Amer­ic­ans to buy any kind of medi­cine on the In­ter­net, of­ten without a pre­scrip­tion, and with no one really in charge of reg­u­lat­ing the on­line mar­ket.

”This is the fu­ture,” says Mi­chael Gury, a spokes­man at IMS Health, the world’s lead­ing pro­vider of in­form­a­tion sys­tems to the phar­ma­ceut­ic­al in­dustry. ”The In­ter­net has just taken every­body by storm.” Jupiter Com­mu­nic­a­tions, a New York City- based re­search com­pany, es­tim­ates that $ 66 mil­lion worth of all health and beauty products will be sold on­line in 1999; by 2002, sales could reach $ 1.2 bil­lion.

Hop­ing to get a handle on on­line drug sales, Fitz­gib­bons was part of a re­cent gov­ern­ment pow­wow con­duc­ted by the House Com­merce Com­mit­tee, where he is minor­ity deputy staff dir­ect­or. Be­cause the Justice De­part­ment, the Fed­er­al Trade Com­mis­sion, and the Food and Drug Ad­min­is­tra­tion have over­lap­ping au­thor­ity over drug sales, of­fi­cials from all three agen­cies at­ten­ded the gath­er­ing to dis­cuss who should reg­u­late the sale of drugs on the In­ter­net. The FDA has primary fed­er­al jur­is­dic­tion, a Justice spokes­man said, but Justice’s Of­fice of Con­sumer Lit­ig­a­tion pro­sec­utes crim­in­al vi­ol­a­tions of the Food, Drug, and Cos­met­ics Act and the de­part­ment’s Drug En­force­ment Ad­min­is­tra­tion has jur­is­dic­tion over vi­ol­a­tions of laws that cov­er con­trolled sub­stances. The FTC has jur­is­dic­tion over In­ter­net drug sales only when de­cep­tion or mis­rep­res­ent­a­tion is in­volved.

Drug sales in cy­ber­space are so new, but grow­ing so fast, that gov­ern­ment and in­dustry rep­res­ent­at­ives are still strug­gling to as­sess the scope of the In­ter­net drug bazaar and its im­plic­a­tions. ”What we want to do is fig­ure out which on­line phar­ma­cies are ques­tion­able and which are ap­pro­pri­ate,” said Jeff Tre­whitt, a spokes­man for the Phar­ma­ceut­ic­al Re­search and Man­u­fac­tur­ers of Amer­ica, which rep­res­ents ma­jor drug com­pan­ies. ”We strongly be­lieve that any­thing that cir­cum­vents the tra­di­tion­al phys­i­cian-pa­tient re­la­tion­ship is dan­ger­ous.”

But there’s noth­ing tra­di­tion­al about the in­creas­ingly ec­lect­ic and luc­rat­ive In­ter­net drug trade. Web sites such as drug­store.com (partly owned by Amazon.com Inc.’s founder, Jeff Bezos) and Riteaid.com re­quire that pre­scrip­tions be faxed or mailed and are re­garded by in­dustry ob­serv­ers as reput­able. But plenty of In­ter­net op­er­a­tions aren’t widely known and are harder to as­sess.

Con­sider, for in­stance, Dir­ect Re­sponse Mar­ket­ing, which has been op­er­at­ing for a year in the Brit­ish Chan­nel Is­lands, selling the anti-bald­ness drug Pro­pe­cia, the anti-obesity drug Xen­ic­al, and Via­gra, mainly to Amer­ic­ans. Man­aging Dir­ect­or Tom O’Bri­en said in an in­ter­view that his com­pany screens pa­tients with on­line ques­tion­naires that are ”scru­tin­ized by com­pany doc­tors,” who fre­quently turn people down, even if they merely sus­pect ”that something isn’t ringing right… . We try to be as con­scien­tious as we can.” He entered this busi­ness be­cause ”the In­ter­net was such an in­ter­est­ing me­di­um with a glob­al mar­ket and low over­head,” O’Bri­en ex­plains.

Cus­tom­ers who use Dir­ect Re­sponse Mar­ket­ing, O’Bri­en says, are know­ledge­able and soph­ist­ic­ated about what they want. ”We don’t so­li­cit any­body. People have to be aware that the drug ex­ists and come to us. We’re not talk­ing about vul­ner­able or gull­ible people. These are people who know how to use a search en­gine and know they want to use a cer­tain drug.”

Car­men Catizone, ex­ec­ut­ive dir­ect­or of the Na­tion­al As­so­ci­ation of Boards of Phar­macy, the trade group for phar­ma­cies, es­tim­ates that there are as many as 200 phar­ma­cies on­line, plus an un­lim­ited num­ber of oth­er kinds of tem­por­ary sites of­fer­ing pre­scrip­tion drugs. ”One site will serve as a shell, and as many as 20 or 30 oth­er sites will feed off of it with a series of hy­per­links. This provides a way of avoid­ing de­tec­tion. There is al­most no ac­count­ab­il­ity, be­cause when you go back, a link that was there may have dis­ap­peared.”

Catizone’s group re­cently an­nounced that it’s de­vel­op­ing a seal of ap­prov­al for on­line phar­ma­cies to help cus­tom­ers de­term­ine which are le­git­im­ate op­er­a­tions. Doc­tors say such a step is ne­ces­sary.

”We have been mon­it­or­ing the situ­ation care­fully,” says Juhana Id­an­paan-Heikkila, the dir­ect­or of drug man­age­ment and policies at the World Health Or­gan­iz­a­tion. ”Be­fore Via­gra was of­fi­cially ap­proved any­where in the world, it was avail­able on the In­ter­net… . No pre­scrip­tions were re­quired.” Pf­izer Inc., which makes Via­gra, found 270,000 Web sites pro­mot­ing or selling the po­tency drug, Id­an­paan-Heikkila said, and ”one of their ex­ec­ut­ives told me that they don’t have the re­sources to con­trol the situ­ation.” WHO has cre­ated an on­line guide with in­struc­tions on find­ing re­li­able med­ic­al in­form­a­tion and as­sist­ance on the World Wide Web.

But at the fed­er­al level, little is be­ing done to curb any ab­uses. FDA spokes­man Brad Stone said the agency is con­cerned about ”any­thing that short-cir­cuits the tra­di­tion­al phys­i­cian- pa­tient re­la­tion­ship,” but the FDA has power only over the drug products and how they are mar­keted, not the doc­tor-pa­tient re­la­tion­ship. ”If you are selling a drug over the In­ter­net, you need to use a leg­al pre­scrip­tion pro­cess, but the de­term­in­a­tion of what qual­i­fies as a leg­al pro­cess rests with the state med­ic­al boards.”

But ask FDA of­fi­cials to guess the scope of the prob­lem and—like every­one else—they’re clue­less. Be­cause the In­ter­net is so sprawl­ing, ”it’s hard for us to have a defin­it­ive num­ber for how many il­leg­al drugs are sold over the Web,” Stone says. ”We just don’t know.”

In the vast­ness of cy­ber­space, an­onym­ity is so easy to achieve that a cer­tain level of an­archy and law­break­ing pre­vails. Add to this the un­cer­tainty about which gov­ern­ment agency is re­spons­ible for the on­line drug trade, and things get even mur­ki­er. And all of the le­git­im­ate dis­pens­ing of pre­scrip­tions that takes place on the Web makes it even harder to isol­ate the trans­ac­tions that are il­le­git­im­ate.

So, who should patrol these on­line drug­stores? Both the FDA and the Amer­ic­an Med­ic­al As­so­ci­ation de­scribe state med­ic­al boards as ”ideal” reg­u­lat­ors. The AMA con­siders the is­sue to be so im­port­ant that its board of trust­ees will is­sue a re­port on the prob­lem at its an­nu­al meet­ing this month. The AMA be­lieves In­ter­net drug­stores are ”a grow­ing con­cern,” one of the trust­ees, Don­ald J. Palmis­ano, said. ”The ex­ist­ence of a pa­tient-phys­i­cian re­la­tion­ship is a pre­requis­ite for pre­scrib­ing. We want to dis­cuss the defin­i­tion of that re­la­tion­ship in light of new tech­no­lo­gies to see if there needs to be any cla­ri­fic­a­tion.”

Din­gell has led the con­gres­sion­al ef­fort to in­vest­ig­ate the In­ter­net drug trade. He has spe­cific­ally asked the GAO to ex­am­ine wheth­er on­line com­pan­ies fall short in veri­fy­ing pre­scrip­tions, and if they do, how of­ten. ”We’ve been con­cerned for a long time about how In­ter­net com­merce would af­fect a num­ber of laws—phar­ma­ceut­ic­als, fire­arms, con­trolled sub­stances,” he says. ”Re­gard­ing phar­ma­ceut­ic­als, we’ve looked at a num­ber of areas—how is the doc­tor-pa­tient re­la­tion­ship be­ing honored? Are the ne­ces­sary steps be­ing taken to en­sure pa­tient safety?” Din­gell men­tioned a fe­male journ­al­ist he knows who ordered Via­gra on­line for her­self and for her cat. She dropped a let­ter from her own name—and ad­ded a sur­name to the cat’s name—so they would seem to be men. ”She didn’t spe­cify her gender,” he notes. ”They nev­er both­er to ask any ques­tions at all. If one per­son can set up that kind of pe­cu­li­ar situ­ation, it’s clear to me that there are oth­er smart people around who can do it too.”

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