HEALTH - Drugs Online: Virus or Cure?

By Suzanne M. Smalley, National Journal
© National Journal Group Inc.
Saturday, June 12, 1999

	      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.''