Sept. 13, 2002
Possibly Illegal Web Sites Selling Anthrax Drugs Exploited Bioterror Fears
Sites Sprang Up Quickly Last Fall, Contained Incomplete Information, Study in The American Journal of Medicine Shows
WASHINGTON, D.C. – Soon after last fall’s outbreaks of anthrax through the mail, a spate of Web sites selling ciprofloxacin without a prescription sprang up, most of which provided poor consumer information, offered few safeguards and charged inappropriately high prices for the antibiotic, a study to be published next month in The American Journal of Medicine concludes. The study was co-authored by Alexander Tsai, a medical student at the Case Western Reserve University School of Medicine, Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, and Dr. Ashwini Sehgal, an associate professor of medicine at Case Western Reserve.
The authors identified 59 Web sites operating during the height of the scare in October 2001, through which consumers could buy ciprofloxacin, the antibiotic widely publicized to treat anthrax exposure. None required that the customer provide a legitimate prescription, as mandated by law. Twenty-three of those sites were created within two weeks after the outbreak’s onset, Oct. 4, 2001. Ten of the 23 stopped selling ciprofloxacin within about a month.
All but one of the post-Oct. 4 Web sites sold only ciprofloxacin, strongly suggesting that they were capitalizing on bioterrorism fears.
“Not only were these Web sites apparently created to exploit the public’s fears, but they also failed to warn of ciprofloxacin’s dangers,” Lurie said. “Almost a third of them contained no information about potentially dangerous adverse effects, and they charged a 50 percent markup over the U.S. wholesale price at the time.”
Patients with a history of hypersensitivity to quinolone antibiotics such as ciprofloxacin could experience life-threatening allergic reactions when using ciprofloxacin, but 16 sites did not warn of that possibility. Eleven sites allowed customers to purchase ciprofloxacin without filling out a questionnaire about their medical history. Overall, two-thirds of the Web sites were deficient in at least one key quality indicator – for example, not mentioning any adverse effects or making a false claim about ciprofloxacin.
Web sites that fill prescriptions can voluntarily join a program of the National Association of Boards of Pharmacy by which they comply with numerous inspection criteria and state licensing requirements. However, none of the sites in the study’s sample had joined the program, showing the inadequacy of this voluntary, self-monitoring approach.
Further, the Food and Drug Administration (FDA) recently opted not to issue guidelines on whether Internet prescription drug sales constitute labeling, leaving the responsibility to regulate these sales largely to the states. However, most states have not enacted laws specific to online sales, and sales across state lines complicate state-based enforcement.
The study’s finding that unethical Web site operators can quickly capitalize on emerging opportunities and shut down just as quickly without being apprehended underscores the need for the FDA to issue strong guidelines and enforce regulations on Internet prescription drug sales, the authors wrote.
“These possibly illegal sites were created quickly, and many vanished as soon as the major money-making was over, but they had ample opportunity to do serious harm to consumers,” Tsai said. “Regulators must have the resources and authority to move just as quickly as these fly-by-night operations.”