Copyright 1999 The Washington Post
The Washington
Post
View Related Topics
May 04, 1999, Tuesday, Final Edition
SECTION: HEALTH; Pg. Z14
LENGTH: 3084 words
HEADLINE:
Drugstore on the Net; It's Quick, It's Convenient and It's Unregulated.
Consumers Run the Risk of Harm With Do-It-Yourself Prescriptions.
BYLINE: Robin Herman
BODY:
As the "information superhighway" starts looking more like a
shopping strip mall, drug stores on the Web are becoming increasingly popular.
In fact, some health industry professionals are predicting that drug sales
online may come to rival the Internet marketing success of books and music.
In the past year, hundreds of pharmaceutical sites have popped up on the
Internet, selling over-the-counter and
prescription drugs and countless health and beauty aids. Most
major pharmacy chains have set up Web sites for ordering products from their
local outlets, and several "virtual pharmacies" have debuted just in the past
two months. These outlets can be private and convenient, offering consumers the
option of making purchases at any time without having to leave home. And because
the virtual stores ship products directly from central distributors to
customers, avoiding the overhead costs of a real storefront building, they
sometimes offer significantly lower prices. They do not, however, always accept
the prescription insurance plans that many patients like to use.
But
next door to some familiar and reputable names like Riteaid.com and
Wal-mart.com, the snake oil salesmen also have set up shop in cyberspace. The
vast potential of a worldwide market and the inability to regulate it have
attracted some operations that skirt conventional medical practices.
Nonetheless, officials from the World Health Organization and the U.S. Food and
Drug Administration took pains in recent interviews not to dismiss this new
option for consumers to get drugs. It is an outgrowth, they said, of the
increasing use of the Internet, which has been extremely valuable in
disseminating lifesaving medical information worldwide.
"This is a
wonderful new media, accessible to everyone, which helps in many ways, in many
circumstances," said Juhana Idanpaan-Heikkila, director of drug management and
policies at WHO. "We know pharmacy companies try their best to follow all
national rules and international ethical criteria."
The problem for
consumers, he said, is distinguishing between the reputable and not-so-reputable
online pharmacies. "How are we going to deal with the information coming from
any source, any company, any person wishing to make money?" he asked. "The
Internet is there, you cannot control it and shouldn't. On the other hand, this
freedom of information can be misused."
The growth of drug sites has
created an international bazaar, with many sites touting unproven herbal
remedies or trendy prescription pharmaceuticals, such as Viagra, the drug to
treat impotence, and Xenical, the diet pill just approved for use in the United
States last week by the Food and Drug Administration. The products are pitched,
sold and mailed directly to customers, often cutting out face-to-face visits
with physicians and pharmacists from the process.
The conventional
online sites work much like mail-order pharmacies. Patients send in
prescriptions from their doctors, and the pharmacies mail the medications to the
patients' homes. But a number of Internet sites also offer home delivery of
prescription drugs either prescribed by an unseen online doctor or without a
prescription altogether. Foreign-based sites will mail medications and
self-treatments unapproved in the United States but available in their own
countries. Other sites advertise products that U.S. health authorities have long
rejected because they simply do not work.
While it is illegal in the
United States for companies to market unapproved drugs, it is not illegal for an
individual to order and accept those drugs--as long as they are for the
customer's own personal use, said officials at the FDA. Those drugs can,
however, be seized by authorities in the mail. It is also illegal to receive
controlled substances, such as narcotic drugs, without proper authority.
"We've always had these catalogues where people could buy from overseas,
but it was a very small market," said Bill Hubbard, acting deputy commissioner
for policy at the Food and Drug Administration. "And people who lived near
Canada or Mexico could buy things more cheaply across the border. The Internet
takes it up a big notch, making it so easy for people to get these products. If
you're timid about going to a physician or don't want to pay a physician, the
Internet is ready-made for you."
Doctor Visits in Cyberspace
Phil Schneider, managing director of public affairs for the National
Association of Chain Drug Stores, said it is too soon for online pharmacies to
have a clear picture of their clientele. But, he said, the Internet drug market
is certainly propelled by an overall boom in prescription drug sales and a
general trend toward self-medicating. Additionally, said Schneider, the millions
of Americans without health insurance may be looking to the Internet to save
money.
His organization reported prescription sales in retail pharmacies
of $ 102.5 billion in 1998, an increase of 15 percent over the previous year.
The sheer volume of prescriptions was up 6 percent.
In February,
Amazon.com, the pioneering giant of Internet book and music sales, inaugurated a
link on its Web site to its new partner, Drugstore.com. This "virtual pharmacy"
offers home delivery of over-the-counter health and beauty items as well as a
prescription drug service, but customers must have a prescription from their
personal physician to get the drugs. PlanetRx.com, a month-old online pharmacy,
also requires customers to mail, phone or fax in their prescriptions.
But other pharmacy Web sites have customers fill out a health
questionnaire--and a liability waiver--and pay a fee of from $ 65 to $ 85 for a
faceless "consultation" with an online doctor, who may then prescribe
medications.
Direct Response Marketing (DRM), a site located in the
British Channel Islands, prescribes and sells so-called "lifestyle drugs,"
treatments that are not medically necessary but purport to enhance quality of
life.
"You are about to discover the answer to every slimmer's dream!"
is the message awaiting customers who visit the site (www.lifestyledrugs.com)
and click on the word "Xenical," the anti-obesity pill that U.S. officials
suggest be used only by people who are clinically obese.
To order
prescription drugs such as Xenical, Viagra, Propecia (for male hair loss) and
Zyban (a smoking cessation aid), DRM's customers begin by filling out a "medical
declaration" that asks for name, height, weight, birth date and whether the
customer suffers from about 10 different medical conditions that would prohibit
him from taking the drug. The form is provided in six European languages plus
Japanese. Customers must also affirm a statement that their answers are
truthful.
According to Tom O'Brien, managing director of DRM, the
company has two doctors who review the forms and issue prescriptions at no extra
fee. Several applications a week are denied, he said, such as in cases where
women order Viagra or men with heart conditions want the drug.
Once the
medical form is completed, customers can click and move forward to the order
form indicating the pills they want, where they should be shipped and credit
card information for payment. Customers can also order by fax.
DRM has
had a big success selling Xenical to customers in Great Britain, where the
national health service supplies the drug only for those who are clinically
obese. Since all pharmacies are run by the government, even non-obese people who
are willing to pay for the drug themselves cannot get it through the national
pharmacies. DRM will prescribe Xenical to people who are only slightly
overweight, said O'Brien.
"It really is a cost restriction put on by the
government," he explained. "It is a very expensive drug, and the sad thing is,
it works very well for women who just have a stone [about 14 pounds] to lose."
As for prescribing drugs like Viagra to customers who have never been
physically examined, O'Brien countered, "There is no physical test a doctor can
do to determine if a person suffers from impotency. The only thing he would know
from examining the person is what he looks like. If someone wanted to lie to get
Viagra, they would get it one way or another."
While DRM provides its
address and phone numbers on the Web, there are many sites that give no
indication of their location or personnel, and there is concern about fraud.
Yesterday Spanish officials announced that they had broken up an Internet fraud
ring that was charging customers for Viagra but failing to send out the
medication. "It's very, very easy to put a very professional page up on the
Internet," said DRM's O'Brien. "People would be very silly to send their credit
card information to an e-mail address with no contact number."
At the
Pill Box Pharmacy, a group of stores located in San Antonio, the pharmacists go
so far as to display their photos and biographies (for example, "an avid pilot .
. . blessed with a perfect tenor voice") on their site (thepillbox.com). Pillbox
charges $ 85 for an online physician's consultation and offers prescription
medications like Viagra, Propecia and Claritin, an allergy drug, and the popular
hormone supplements melatonin and DHEA.
Pill Box requires customers to
read an information page about the drugs they are ordering and click agreement
to an extensive liability waiver. Then a medical questionnaire appears on the
screen asking about known allergies, current medical conditions and medications
being taken.
It's obvious, said pharmacist William A. Stallknecht, one
of the Pill Box's founders, "that privacy is a real big issue" for people
looking for drugs on the Internet. He fields online Viagra requests from local
addresses and from doctors who themselves need the impotence drug. He said
medical questionnaires are screened three times, including an automated initial
rejection if a customer notes that he is also taking a medication that conflicts
with Viagra or checks any illness that would be affected by the drug. "We really
haven't had any problems" with fraudulent online applications, he said, adding,
"You can lie in person."
Physicians' Growing Concern
Still,
mainstream medical groups are not enthusiastic about some of these practices.
Prescribing without a physical examination of the patient "is unethical but not
illegal," said Nancy W. Dickey, president of the American Medical Association.
The AMA has advised its members not to prescribe over the Internet and has urged
doctors to report others who do to their state medical boards.
States
require licensed doctors to meet a "standard of care" for a physician-patient
relationship that includes personal interaction. Nevada's Board of Medical
Examiners recently specifically barred its doctors from making Internet sales
unless they actually see the patient. Medical boards in Wisconsin and Colorado
have taken disciplinary actions against doctors prescribing over the Internet to
patients they have never examined. Other states have ongoing investigations and
have sent "cease and desist" letters to Internet prescribers, according to the
Federation of State Medical Boards of the United States. Some states do not even
allow physicians to fax or e-mail prescriptions to drug stores.
Critics
worry that without a face-to-face meeting with a doctor, customers can easily
lie about their age and health status in order to get the regulated products
they want--such as diet pills meant only for the clinically obese.
"Certainly a patient can come into a doctor's office and lie," said Dale
Austin, deputy executive vice president of the Federation of State Medical
Boards. "But the doctor can see their approximate age, their obesity, listen to
their heart, take a blood pressure reading. On an Internet questionnaire you can
be anyone you want."
The AMA's Dickey said Internet drug sales that
bypass a doctor's examination are most dangerous for the elderly, "because they
are more likely to have . . . a conflicting chronic disease that could pose
risks." People on long-term medications are also vulnerable to adverse drug
interactions, she said. Viagra, for example, can lower blood pressure to
dangerous levels in people already taking blood pressure medicine for
hypertension.
There is also growing concern about the availability of
some narcotics on the Internet, said Dickey. At least one site offers Tylenol
III with codeine without a prescription. The U.S. Drug Enforcement
Administration is grappling with these issues, said spokesperson Ragene Waite.
Regulators and health organizations such as the FDA, the AMA, the World
Health Organization and the National Association of Boards of Pharmacy (NABP)
have watched the growth of Internet pharmaceutical sales with apprehension for
consumer safety. They express frustration at trying to regulate and police the
borderless territory of cyberspace where no agency has total authority.
"The medium has attracted a visible band of unlicensed and unscrupulous
entrepreneurs who are interested only in a quick profit, often at the patient's
expense," according to a statement from the National Association of Boards of
Pharmacy. "These sites frequently operate for a short time at one Web site
address before disappearing and setting up shop under another name to escape
detection."
FDA Warns of Deadly Drugs
Encouraged by the FDA, the
Boards of Pharmacy association is launching a program to help consumers find
reputable online outlets. The association is offering a certification to sites
that apply and meet certain standards. Then the association will post a list of
those that have valid licenses on its Web site (www.nabp.net) and verified
pharmacy sites will be allowed to display a special seal from the association.
The FDA, which can regulate products in the United States but cannot
necessarily control how they are sold, has issued consumer warnings and import
alerts about various unapproved or adulterated products available through the
Internet.
In January the FDA warned the public about deadly "dietary
supplements" containing gamma butyrolactone (GBL) being touted as a muscle
builder and sex enhancer. It said these illegally marketed, unapproved products
had killed one consumer and caused severe reactions in 54 others, including
coma, unconsciousness and seizures. The FDA asked manufacturers to recall the
products. Yet some sellers are still advertising GBL on the Internet.
Two years ago the FDA was able to shut down a Web site selling hazardous
home abortion and female self-sterilization kits. Since the site was being run
out of Bogota, Colombia, the FDA had no jurisdiction there. But the site had a
contract with a U.S. Internet service provider that required adherence to all
U.S. laws, explained Dwight Rawls, senior operations manager at the FDA's Office
of Criminal Investigation. The FDA informed the service provider it was
violating the law by aiding the distribution of an unapproved drug and could
possibly be liable for injuries linked to the product. The service provider
dropped the Web site.
Customs and postal agents have intercepted
packages of illegal products ordered online, but many packages still make their
way through the mails. Online pharmacies selling unapproved drugs typically
include in their advertising a caveat explaining that they are not responsible
for the drugs being delivered, such as this one from the Viagra-Global.com Web
site: "We cannot accept any liability for the nondelivery of any products due to
the actions of any government once shipment has left our port of exit."
"The public are enthralled by the ease and privacy" of Internet drug
sales, said Austin, of the medical boards federation. "But some of the
safeguards are missing and can be of grave concern to their health and their
pocketbooks, too."
The launch of Viagra last year brought into focus the
potential market and potential for abuse of Internet drug sales. Scores of sites
on the Web will prescribe the drug after the customer fills in a questionnaire
stating that he has an impotence problem but is otherwise healthy.
Viagra generally has only minor side effects, but it can be dangerous
for anyone taking nitrate drugs, including nitroglycerine, which, together with
Viagra, could suddenly lower blood pressure to an unsafe level. Also, sexual
activity itself may pose a risk for some people with heart problems, a situation
a doctor can only assess through a physical examination.
While Viagra
under prescription from traditional pharmacies sells for about $ 12 per 50 mg.
pill (with doctors placing limits on the number of pills per month), prices on
Internet drug sites range from $ 4.50 to $ 26 per pill and patients can get as
many as they like. That expensive pill was available from Viagra-Global.com,
which lists its address in the Canary Islands and does not require a
prescription for Viagra.
Randy Wykoff, associate commissioner for
operations at the FDA, warns that "consumers need to understand that there is a
value added by the involvement of the pharmacist and physician, that products
from other countries don't always deserve the confidence people have in products
from this country. When they go outside the system, there are risks that they
run."
The World Health Organization has considered the problems of
Internet drug sales, but international action is nearly impossible because of
different prescription standards in each country. Nonetheless the WHO urged its
member countries to apply their particular laws to Internet pharmacies and to
cooperate in blocking illegal cross-border sales. Meanwhile, the WHO is working
on guidelines for consumers to help evaluate Web sites that offer drugs and
health information.
"With the freedom of the Internet, the world is the
market, not just the United States," said Stallknecht, the Pill Box pharmacist
in San Antonio. "Ninety-nine percent of the world won't be affected by what we
do here. There is no control, and there can't be because no one can open your
mail for you every day."
He said the best safeguard is information, and
people are better informed today about medical issues than ever before. "You
have to look out for yourself because you care more about your own health than
any doctor or government does. It's the old caveat emptor." The vast array of
merchants selling drugs on the Internet range from those associated with large
U.S. retail pharmacies to foreign vendors.
GRAPHIC: Illustration, ross macdonald; Photo
LOAD-DATE: May 04, 1999 
