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March 9, 2000 (Washington) — A split-second ride fueled by a powerful
Internet search engine reveals the extent of the problem: type in
“Viagra” and nearly 60,000 results come flying back. But those
flashing, dancing, web sites that proclaim, “No prescription? No
problem,” are best avoided, says an Ohio physician who analyzed the risks
of buying the impotence drug via the World Wide Web.
“There are no regulations now, and the government is moving very slowly
to corral the practice of online prescribing,” says Steven E. Kahan, MD,
the lead author of the article in the March issue of the Journal of
Urology. “This is obviously something that is very tough to get your
arms around. Then, after everything is said and done, you have the
international sites, and I don’t know who is going to regulate them.” Kahan
is an attorney and urologist-in-training at Case Western Reserve University in
Cleveland.
However, in a letter published in the March 8 issue of TheJournal
of the American Medical Association, Jane Henney, MD, commissioner of the
FDA, acknowledges that laws need to be updated and writes that the agency is
working with state pharmacy and medicine boards to “investigate illegal
online selling and prescribing.”
Viagra (sildenafil) has been available since March 1998 for the treatment of
impotence, or erectile dysfunction (ED). It has been hawked in television
commercials by Bob Dole, the former senator and presidential candidate. The
most common side effects of Viagra are facial flushing, nausea, dizziness and
blue-tinged vision, but it can also cause a potentially deadly drop in blood
pressure, when combined with certain medications, including
nitroglycerin.
In the article, Kahan and two colleagues trace the advent of Viagra’s
through the Internet and focus on the ethical, legal, and
regulatory issues that surround online prescribing in general. The authors
write that the physician-patient relationship was under stress before the
popularity of the Internet. The increasingly common practice of phone calls to
patients altered this arrangement, with patients expecting “attention to
medical needs” and a guarantee of privacy during such calls.
At first, physicians turned to the Internet primarily as a means to
communicate with colleagues and conduct research, but now more realize it can
“permit easier patient access to health care and lower transaction costs
with arguably continued consistent health care delivery,” the authors say.
Improved patient compliance may also be achieved.
The authors argue that regulations should recognize a distinction between
Internet pharmacies and online prescribing and point out that a variety of
governmental agencies have a limited hand in such regulation today. While the
FDA ostensibly has oversight of prescription medications, it does not regulate
the actual writing of such medications, but only the “development,
distribution, and promotion” of .
There is little harm in people filling prescriptions written by their
physician through reputable Internet pharmacies. But that’s where the sites’
involvement should begin and end, Kahan says.
“I think Internet pharmacies should not initiate a prescription, and the
prescription that is filled should be based on a doctor-patient relationship,
and that usually involves a physical exam,” says Kahan. In his own
practice, Kahan says he found it “strange” that patients had access to
medications he deemed inappropriate for them and “all I could do was warn
them about what might happen and discourage them for getting it from the
Internet. Hopefully, they would have the sense not to get it.”
State governments have cracked down on physicians who have prescribed
medications online to people who don’t reside in the states where the
physicians are licensed, holding that it constitutes practicing medicine
without a license. The Federal Trade Commission is charged with ensuring that
drug advertising is not false or misleading, although monitoring Internet
claims specifically seems to have gotten little emphasis, Kahan says.
Irwin Goldstein, MD, a professor of urology at Boston University, points out
that patients should have a thorough examination before they are given Viagra
to rule out any possible interaction with other medical conditions they have.
He tells WebMD that a “doctor’s visit” by an online physician could
miss the possible reasons for erectile dysfunction and other medical conditions
that could make Viagra a bad idea, including diabetes, hypertension, high
cholesterol, kidney failure, anemia, prostate and testicular infections, and
depression.
For Robert Sher, MD, a urologist in Maryland, the article reinforces his
belief that prescribing and obtaining Viagra over the Internet are just
wrong.
“Viagra has side effects,” says Sher, who reviewed the article for
WebMD. “People need to be monitored on it. If they aren’t monitored they
can die. You need to see the patient. ED is a medical problem and patients need
to have a thorough evaluation prior to prescribing it. Viagra is not for
patients who are using nitroglycerin products and may be abused by someone who
just wants it as a sex enhancer.”
Though none of his patients have discussed obtaining Viagra through the
Internet, the possibility certainly exists that they could get it this way,
Sher says. “You see these sites everywhere. They advertise in the
newspaper, and I think Viagra is probably the tip of the iceberg of what other
drugs you can get on the Internet.”
In her letter to JAMA, Henney also counsels that patients not obtain
first-time prescriptions from online doctors, and she urges physicians and
pharmacies to “educate their patients about dangerous online
practices.” The agency “also encourages health care professionals and
patients to report any suspicious web sites to the FDA or the National Boards
of Pharmacy. Until fully effective safeguards are in place, patients and health
care providers should be cautious when using or the use of the
Internet for purchase of prescription medications,” she writes.
Vital Information:
- Experts are concerned about the ease with which the erectile dysfunction
drug Viagra is obtained over the Internet without a prescription or a visit to
a doctor.
- One problem is that regulation of prescribing over the Internet is
fragmented among government agencies, although governing practices may be
changing in the future.
- Getting a prescription filled by an online pharmacy should not be a problem
for consumers, as long as the prescription was written based on a sound
doctor-patient relationship that involves a physical exam.
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