11-13-1999

HEALTH: Drugs on the Web

Suffer from high blood pressure? Chronic back pain? Depression? For years,
getting prescription drugs meant a trip to the doctor, possibly tests and
lab work, and, finally, a trek to the local pharmacy. From appointment to
pills, the process could take weeks. Today, getting prescription medicine
can be as easy as clicking a computer mouse and typing a credit card
number. That's what I did. Using a search engine, I found more than 100
Internet sites that were hungry for my


business. Some wouldn't sell me medication without a signed prescription
from my doctor, but others boasted, in bold type with exclamation points,
that no prescription was needed. Still others said their cyberdoctor would
conduct a virtual exam and--voile!--prescribe medication.


I chose Alant's Pharmacy, which is located in Homestead, South Africa. I
filled out a brief physician's questionnaire that asked for lots of
financial information and my mother's maiden name, but made no inquiries
about my symptoms. Eight days after authorizing payment of $143 on my
credit card, I received a nondescript box in the mail that looked as if it
might contain cookies from Grandma.


There was no indication that a pharmacy had sent the package. The customs
declaration form stamped on the box said it contained echinacea, a
seemingly harmless dietary supplement that can be purchased over the
counter to ward off colds. But the package did not contain echinacea.
Inside were three potentially harmful prescription drugs that I had
ordered:


* Accutane, which is used to treat acne, can cause severe birth defects
and liver toxicity; in this country, doctors require patients to sign a
consent form that lists the possible dangers in using this drug. (I was
presented with no such document.)


* Empacod, a pain reliever equivalent to Tylenol with codeine, can be
addictive.


* Amaryl, which is used to control diabetes, can lower glucose levels and
cause death without regular monitoring and dosage adjustments.


Welcome to e-commerce. And let the buyer beware. Although shopping on the
Internet has the wonderful potential to make the world's vast marketplace
more accessible to everyone, from the homebound elderly to busy parents,
it also has the ability to skirt health and safety regulations designed to
protect consumers.


"It's kind of the Wild, Wild West out there for prescription drugs on
the Internet," Rep. Ron Klink, D-Pa., told National Journal.


In America, the licensing of pharmacies and doctors is a state
responsibility, and--theoretically--states have the ability to prosecute
Internet sites that aren't licensed to ship drugs to state residents. But
it's hard for states to act if they can't figure out where a cyberpharmacy
is headquartered or where it's licensed to do business.


Klink, along with John D. Dingell, D-Mich., the ranking member on the
House Commerce Committee, is pushing legislation that would direct the
Food and Drug Administration to require Internet pharmacies to disclose
their physical locations and where they are licensed to dispense
drugs.


When I browsed the Internet, it was impossible to determine where many of
the pharmacies were located and licensed. In some cases, clicking on
"Who we are" led to nothing more than a vague message from
"the president" of the business. The name of the company never
appeared, and the name of the president also remained a mystery. This may
be why only three states have begun prosecuting cyberpharmacies.


At the federal level, several agencies have jurisdiction over various
aspects of prescription drug sales over the Internet. But, says Klink,
none of them appears eager to take the lead. "I started looking at
this issue in January," he said, adding that he sought help from the
FDA, the Justice Department, and the Federal Trade Commission but got
nowhere. "Everyone pointed their finger at everyone else. It became a
real concern for us."


But a larger issue may be one that is philosophical in nature--the concern
of government officials and influential members of both parties on Capitol
Hill that a blunderbuss approach to regulating e-commerce could stifle the
growth of the Internet. "The general position is one approximating
laissez-faire," said Rep. Adam Smith, D-Wash., a New Democrat.
"Make sure you don't kill the golden goose."


"Clearly in the last couple of years," said high-tech industry
observer Rob Atkinson, "there's been a big fight among the parties
about which party is friendlier to and understands the high-tech
community. The party that understands the high-tech community understands
the economy." Atkinson is the director of the Technology and New
Economy Project at the Progressive Policy Institute, an arm of the
Democratic Leadership Council.


Certainly the Clinton White House has taken a minimalist approach to
regulating e-commerce. "The Administration is erring on the side of
`Let's slow down and not jump in right away,' " said Atkinson.
Congressional Republicans are also reluctant to institute controls. House
Commerce Committee Chairman Tom Bliley, R-Va., said that it is important
not to overreact to the possibility of some abuses by "piling layers
of new regulations onto an emerging marketplace. I am excited about the
promise this new marketplace brings to working families, the disabled, and
senior citizens across the country."


Carmen Catizone, the executive director of the National Association of
Boards of Pharmacy, located in Park Ridge, Ill., estimates that pharmacies
in the United States will fill 3 billion prescriptions this year, and that
Internet sales will account for somewhere between 1 percent and 10 percent
of them. "No one's been able to clarify how much of the market they
actually have and how much they're seeking," he said.


Of course, lots of people have a stake in finding potentially cheaper ways
of getting medications. More than 44 million Americans (one in six) are
uninsured, and only about one-third of older Americans have insurance
coverage for prescription drugs. Medicare doesn't have a prescription drug
benefit, and the supplemental coverage that many Medicare beneficiaries
have is considered minimal. Both Republicans and Democrats in Congress
agree that a new Medicare benefit is needed, but they haven't been able to
work out a solution.


No Prescription? No Problem


At the beginning of the year, fewer than 50 Web sites were selling
prescription drugs. Now, there are more than 400. "I'm deeply
concerned that some drugs are being dispensed in a manner that constitutes
dangerous practice," said Herman I. Abromowitz, a family physician
from Dayton, Ohio, who is a member of the American Medical Association's
board of trustees.


Abromowitz isn't worried about the many cyberpharmacies that require
customers to send in a handwritten physician's prescription. What concerns
him are the cyberpharmacies that don't require prescriptions or that sell
drugs to people willing to take a cyberexam.


What's happening in cyberspace is that Americans are getting a taste of
what it's like to obtain medications abroad. Many countries don't require
prescriptions for drugs such as anti-depressants, birth control pills, and
antibiotics. When I went on the Internet, I could have ordered anabolic
steroids (for muscle-building), Viagra (for sexual dysfunction), or
Propecia (for hair loss). There were endless offerings of weight-loss
pills, anti-psychotic drugs, and blood pressure medications. All you have
to do is connect with a search engine like Yahoo! and enter the name of
the drug you want in the search field. Click, and the world of
cyberpharmacies magically unfolds.


The federal rules governing imported prescription drugs are unclear. I
called both the FDA and the Drug Enforcement Administration to find out
whether it was legal to place an order with a South African pharmacy.
Officials at both agencies assured me that I could import any FDA-approved
medicine without a prescription if I used the drug personally and limited
my order to a 90-day supply. After I had placed my order, an official at
the FTC informed me that my order was illegal, and that the 90-day,
personal-use exemption applied only to medications unavailable in the
United States, such as experimental drugs.


Many cyberpharmacies are seeking customers by e-mail. In October, one
National Journal reporter received on his personal e-mail a solicitation
advertising Viagra, Propecia, and Xenical (for weight loss). "STOP
paying a Doctor's Fee every time you need a refill," the solicitation
read. "We give ALL our CUSTOMERS UNLIMITED REFILLS on just 1
Consultation fee. We are the ONLY SITE to offer this GREAT DEAL, this is
why WE have over 3,000 customers." (Actually, I saw several sites
that made that claim.)


Hundreds of domestic and foreign-based Web sites offer to sell
prescription drugs to anyone who agrees to take the kind of pro forma
cyberexam that I did. Many of the consultation questionnaires have large
sections that are already filled in and that suggest what the
"right" answers are.


"The quality of physician Internet care is uncertain, and potential
for serious abuse exists," warned Bernard S. Bloom, a research
professor at the University of Pennsylvania in Philadelphia.
"Patients can easily provide incorrect or false information to obtain
medications."


Bloom and Ronald C. Iannacone, a university graduate student, recently
released a study of 46 Web sites that they examined in February and March
of this year. Bloom said they asked every site to provide the name and
address of the consulting physician, but none did. Thirty-seven of the 46
sites required a prescription from a personal physician or from an
Internet physician based on a consultation. Nine sites--all
foreign-based--required neither a prescription nor a consultation with a
physician.


According to Bloom, the first thing the sites tell you is what drugs they
have to offer. "The second thing these sites tell you is that, if bad
things happen, they're not liable. The third thing they ask you for is
your credit card number. Then they ask you what's wrong. It's obvious to
us that they're there to sell the medications. Some of them would sell you
anything you wanted." Bloom said customers have no way of knowing
whether the medication they receive is the real thing, superpotent,
subpotent, or counterfeit.


Despite his criticisms, Bloom isn't agitating for new regulations or laws.
"Why shouldn't someone do something stupid if they want, and kill
themselves?" he asked. "If you're willing to pay more for
improved convenience and access, but also take the risk that you're not
getting the right medication, or right dose, then you ought to do
it."


In fact, Bloom said that it was more expensive to purchase drugs from the
Internet sites he examined than from the corner drugstore. The cost of a
physician cyberexam ranged from $20 to $90. The median price was $70,
which is actually 15 percent higher than what Philadelphia physicians
charged for office visits. Bloom found that the median price per pill,
before shipping charges, was higher by about 10 percent.


Budding cyberentrepreneur Larry Burstein agrees with Bloom that consumers
should be free to make their own decisions, even if they're bad ones.
"If people are wanting to get narcotics for abuse, they're going to
find a way, whether they're buying it on the street or over the Internet.
But we're not all policemen."


Burstein runs www.drugquest.com, a Sarasota, Fla.-based Web site that, for
$65, provides lists of thousands of pharmacies throughout the world that
sell prescription drugs on the Internet without a prescription. He also
offers lists of physicians who will consult with a patient on the phone or
the Internet and write prescriptions when necessary.


Burstein, who was once a monk in India, says that he doesn't use any
prescription medications himself. "I don't even drink tea," he
said. He's had two operations on his back and says he was once addicted to
pain-killers. Burstein said he became acquainted with foreign mail-order
medication when he wanted to obtain Accutane (the acne drug I ordered from
South Africa) for his son. Because he wasn't insured, he couldn't afford
to get it at the local drugstore, so he ordered it from a foreign country
for a fraction of the cost.


"What we're talking about is people who can't afford medications and
can't pay a doctor to renew prescriptions, and here's a facility where you
can get Valium for 8 cents apiece. It's sold over the counter in most
foreign countries," Burstein said.


Burstein launched his Web site a year and a half ago, and he estimates
that more than 17,000 people have purchased his lists. "It's a myth
that pharmaceuticals made in foreign countries are manufactured with low
standards. They don't want to kill off their populace."


Burstein admits there are dangers that drugs will interact badly or that
people won't get proper medical supervision. "But is that danger
outweighed by people on welfare who can't afford drugs? I don't get
involved in the philosophical part of this."


The Federal Role


Web sites like Burstein's prompted Klink to introduce his bill and, with
Dingell's support, push for Commerce Committee hearings. On July 30, he
got a hearing before the Oversight and Investigations Subcommittee, at
which several consumers stated that the Internet pharmacies had made their
lives easier. Republicans at the hearing made clear their intention to
move slowly into the regulation of e-commerce.


Klink says his bill is not intended to stop sales but to insist on
disclosure. "We're trying to say that anyone selling has to have the
same information available that local pharmacies have on the corner. They
need to say who they're accredited by, where they're licensed to practice
medicine."


Some states have begun cracking down on cyberpharmacies. Illinois and
Kansas recently sued cyberpharmacies operating in their states. And on
Oct. 21, prosecutors in Illinois filed four lawsuits against
cyberpharmacies that were unlicensed in that state, but were selling
prescription medications and offering online consultations with
doctors.


According to Klink, more cyberpharmacies would be prosecuted if they
weren't so hard to identify. "We need to help states decide who's
legitimate and who's not. We need to serve as a resource for states to
call upon," he said.


Several federal agencies have some jurisdiction over cyberpharmacies,
including the FDA, the FTC, the U.S. Customs Service, and the DEA. But
critics complain that none of the agencies has taken the lead. "No
one has jumped to the forefront to embrace the first step," said
Klink. "The Administration is not asserting themselves. ...There's
evidence people are dying, people are being hurt by these drugs, and when
I asked the FDA how many people they put on this problem, they said 10.
[Now it is 20, according to the FDA.] They have 9,000 employees."
Klink said that the White House should be coordinating an offensive. But
Administration officials counter that it's too early to know whether new
federal laws are needed. That's why President Clinton, in an August
executive order, created a working group to investigate unlawful conduct
on the Internet. Attorney General Janet Reno is heading the group, and its
report is due in early December.


Jeffrey Shuren, a medical officer at the FDA, said the FDA is the lead
Administration agency on the matter. "We are getting a better sense
as we work on the issue and with the states," Shuren said. Under
current law, the FDA has the authority to go after domestic sites that are
selling drugs without a valid prescription. Shuren said the FDA has
examined more than 100 Web sites and has 50 ongoing investigations into
sites that may be selling drugs improperly.


The FTC, meanwhile, has authority over deceptive medical information that
appears on the Web. For example, if a site claims that a physician is
reviewing medical information to write a prescription and there is, in
fact, no physician, or if the site claims that the information will be
kept private and then sells or gives it to a direct-mail company, the FTC
has a case against the site. Richard Cleland, a senior FTC attorney who is
handling the agency's response to cyberpharmacies, said that most sites
the agency has reviewed do not have adequate privacy safeguards.


But Cleland said he is most concerned about foreign sites. "In most
cases, some state or federal agency could get a federal injunction. But
the issue becomes enforceability of that injunction," he said.
"The domestic side of this issue can be solved and handled if all
parties with jurisdiction work together. I'm not as confident about the
international part of it." Some federal agency, perhaps the Commerce
Department, will have to negotiate understandings with other countries on
this issue, he said.


Cleland notes that the FTC has some ongoing investigations but is not
ready to prosecute. "It could be a while yet," he said.
"There's nothing cookie-cutter about this. It's difficult to locate
the responsible parties, and the violations, at least from FTC's
perspective, are fact-intensive and require a lot of work."


Many of the sites, according to Cleland, are essentially boiler-room
operations. They set up shop "for a short period of time, then they
take down the operation, move it, and it comes back under a different
name. By the time law enforcement officers target them, they've
disappeared."


Customs officials say they are similarly hamstrung. "The problem we
run up against is that these Web sites are located outside our
borders," said Kevin Delli-Colli, director of the U.S. Customs
Service's Customs Cybersmuggling Center in Fairfax, Va. "Until we can
work up bilateral agreements with foreign governments as to how electronic
commerce is going to work, being respectful of each other's laws, the only
thing we can do is be more vigilant at the borders in deterring people
from ordering" prescription drugs overseas.


Delli-Colli said he wasn't surprised that Alant's had lied on the customs
declaration form. "I know [the companies] are doing that," he
said. "Some sites go as far as to say they will assist in providing
vague information to help speed the stuff through customs."


The Legitimate Ones


By no means are all Internet pharmacy sites anything-goes operations.
Searching for pharmaceuticals on the Internet can turn up familiar names
such as CVS, Walgreens, and Wal-Mart. There are also sites that don't have
retail outlets but adhere to traditional standards for selling
pharmaceuticals. They obtain licenses in each state in which they sell,
and they require a customer to send in a written prescription from a
physician.


Bill Razzouk, the chairman and CEO of PlanetRx.com, which just went
public, calls his cyberpharmacy a chain with 70 million branch stores--a
reference to the number of computers hooked up to the Internet. "Like
your family's pharmacy, we authenticate all prescriptions before filling
them," Razzouk said at the July Commerce Committee hearing.
"Like your family's pharmacy, we check to confirm that the
prescribing physician is a properly licensed physician with a current DEA
number. And, like your family's corner pharmacy, at PlanetRx.com we do not
prescribe drugs, we only dispense them. We do not interfere in any way
with the sanctity of the patient-physician relationship."


Razzouk said the dilemma facing authorities is "how to eliminate
these unprincipled operators, while fostering the responsible, legitimate
online pharmacy business in a way that will benefit consumers and protect
their health interests."


At this point, Razzouk and the National Association of Boards of Pharmacy
are not supporting legislation such as Klink's. "Eliminating the
Internet equivalent of back-alley drug sales does not require new
legislation; all it requires is the vigorous enforcement of the existing
state and federal laws," Razzouk said. He and the association also
support more industry self-policing.


For instance, the association has begun its own credentialing process.
Cyberpharmacies pay a fee, answer a number of questions about where they
are licensed, submit to an inspection, and--if they pass muster--get a
seal of approval they can display on the Web. PlanetRx.com was one of the
first Web sites to get such a seal. But critics note that it's a voluntary
program, and that consumers don't know whether a site without a seal is
legitimate or not. On Nov. 9, Razzouk hosted a summit meeting of online
pharmacy executives in Washington.


And how will Alant's, the South African pharmacy that sent me the brown
box with medications inside, fit into the picture? It's anybody's
guess.


Andre Van Vuuren, the pharmacist at Alant's, said that the physician
Alant's uses to write online prescriptions is "very strict" and
carefully checks questionnaires for inappropriate orders, such as ones
from possible drug addicts. "There are quite a few requests that he
declines," he said.


But when I asked him how any doctor could make an informed decision about
prescribing medications on the basis of a questionnaire that doesn't even
ask about a patient's symptoms, there was a long pause. Van Vuuren then
said that Alant's was planning to start asking for that
information.


When I asked him why the customs declaration form on the outside of my
package incorrectly stated that the box contained echinacea, he said that
Alant's "used to" do that to avoid customs delays. (I talked to
Van Vuuren five days after I received my order.)


Van Vuuren said that the pharmacy is still ironing out the details of
online prescription selling. He repeated several times that this is all
"very, very new. We are still quite young in this
thing."


Then he added, "This is the future. Some people like it. If you don't
like it, you mustn't use it."


Marilyn Werber Serafini

National Journal