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 on 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 Dr. 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," said Lurie. "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