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Web sites selling the prescription-only medication ciprofloxacin
(also known by its brand name Cipro) sprang up quickly following
an anthrax outbreak in October 2001, according to a new study
by researchers from the CWRU School of Medicine.
The study, published in the American Journal of Medicine, also
found that these Web sites provided poor quality information,
had inadequate consumer safeguards and charged high prices.
On Oct. 4, 2001, the U.S. Centers for Disease Control and Prevention
reported the first case of an anthrax outbreak by mail. Immediately
following the anthrax outbreak, numerous Web sites began selling
ciprofloxacin, then the only U.S. Food and Drug Administration
(FDA)-approved drug to treat anthrax exposure. The outbreak provided
the research team with a unique opportunity to illustrate the
general difficulties regulators have had with these so-called
"Internet pharmacies" that sell prescription drugs directly to
the general public.
The researchers compiled information from 59 Web sites selling
ciprofloxacin without a prescription between Oct. 28 and Oct.
31, 2001. Twenty-three sites (39 percent) had been created during
the two weeks following the Oct. 4, 2001, announcement of the
anthrax outbreak. Within a month, 29 sites (49 percent) had discontinued
ciprofloxacin sales.
"The host of Web sites we identified sprouted up within two weeks
of the anthrax outbreak-one outbreak immediately following the
other," said Alexander Tsai, a fourth-year CWRU medical student
in the dual degree program in medicine and health services research.
"These online sales of prescription-only medications clearly do
not involve any meaningful medical assessment, which is necessary
when prescribing a potentially dangerous antibiotic like ciprofloxacin."
Most state medical practice acts stipulate that a physician must
examine a patient before prescribing a medication. However, none
of the Web sites in the CWRU study required the customer to mail
or fax in a physician's prescription. Forty-nine sites (81 percent)
simply asked the customer to fill out an online questionnaire
with minimal questions about the customer's medical history and
symptoms. The other eleven sites (19 percent) did not even require
customers to fill out a medical questionnaire for purchase.
Tsai conducted this study with the help of Peter Lurie, deputy
director of the Washington D.C.-based Public Citizen's Health
Research Group, and Dr. Ashwini Seghal, a nephrologist at MetroHealth
Medical Center and an associate professor of medicine at CWRU.
The researchers also had concerns about the quality of these
Web sites. Seventeen of the 59 sites (29 percent) displayed no
information about potential adverse effects, and 16 sites (27
percent) did not mention the danger of life-threatening allergic
reactions if patients with a history of hypersensitivity to quinolone
antibiotics (such as ciprofloxacin) use the drug. On eight sites
(14 percent), the researchers documented false or misleading claims.
During the study period, state authorities brought enforcement
actions against three of the Web sites in the CWRU study. Also
in response to the Internet explosion of Web sites selling ciprofloxacin,
the FDA ordered all private ciprofloxacin shipments arriving from
overseas to be stopped at the border. Eleven of the 59 sites (19
percent) were based in foreign countries, while the rest were
registered to U.S. addresses.
"The sale of prescription drugs on the Internet is both a federal
and state issue, but neither has the resources or adequate legal
authority to act quickly enough," Lurie said. "The problem is
that feds have largely deferred to the states-but the states have
not filled the regulatory vacuum."
Tsai said he was inspired to undertake the research project after
studying the work of other researcher-activists. Sehgal teaches
an "Activism and Medicine" elective class for CWRU medical students.
More information about this class can be found at http://home.cwru.edu/activism.
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