Anthrax Kits in 114M U.S. Homes Gets FDA Scrutiny
Making anthrax-antidote kits available to the 114 million households in the U.S. in case of a bioterrorism attack may lead to misuse of the medicines and stir up public fears, regulatory advisers said.
“People may infer an anthrax attack is imminent,” Thomas Moore, chairman of a Food and Drug Administration advisory committee, said in an interview yesterday after a meeting on the subject. “It may have an adverse impact on doxycycline,” the antibiotic that was hoarded after the Sept. 11, 2001, terror attacks, he said.
The FDA met with panels of scientists and academics to consider whether kits containing a 10-day supply of doxycycline should be available for all Americans to store in their homes in preparation for a bioterrorism attack. A branch of the Health and Human Services Department said it wants to start with 10 million first responders and their families before expanding it to the rest of the population.
“The public just looks at the system as there you go again crying wolf,” Diane Cappelletty, an associate professor of pharmacy practice at the University of Toledo College of Pharmacy, told the committee during the meeting.
Consumers could misuse the so-called medkits by taking them for reasons other than an anthrax attack, a move that may exacerbate antibiotic resistance, the advisers said. A test run in 2007 with about 4,200 households in the St. Louis area showed some instances of misuse, including one person who took the doxycycline during an emergency declared for a snow storm, and two others who used the tablets to treat sore throats.
Fallout Shelter Craze
“I can’t help but be reminded of the decades old fallout shelter craze,” Marcus Reidenberg, a panelist and professor of public health at Weill Cornell Medical College in New York, told the FDA committee. “It’s assuming that everyone in the U.S. knows we have doxycycline and no one in any organization that might want to attack the U.S. doesn’t.”
The FDA today and April 4 also will hear arguments for the wider availability of ciprofloxacin and Johnson & Johnson (JNJ)’s Levaquin to treat any terrorist-initiated outbreak of pneumonic plague, according to documents on the FDA’s website. The disease is the most serious of three forms of plague that occurs when the bacteria infects the lungs, and can be spread from person to person through coughing and contaminated articles.
The FDA would require more studies for an anthrax medkit like those conducted for over-the-counter drugs to ensure consumers understand the product correctly, Barbara Cohen, a social science analyst at the agency’s office of drug evaluation, told the advisers.
Only potassium iodide is available for home storage for similar threats, George Korch, a senior science adviser in the Health and Human Services office of the assistant secretary for preparedness and response, said during the meeting. Potassium iodide tablets combat exposure to radioactive iodine and are available on the Internet, according to the FDA.
The government stores “tens of millions” of 60-day courses of treatments in case of simultaneous attacks to dispense after an event, Korch said.
National leaders first brought up the notion of household medkits in 2005, four years after five people died from anthrax found in letters. Expanding the products to the rest of the population was put on hiatus because of concern for misuse and antibiotic resistance. President Barack Obama resurrected the idea in 2009 when he instructed the government to plan for a biological attack, Korch said.
Home kits could relieve the burden on community dispensing centers, which are unlikely to be able to meet a two-day deadline to hand out drugs to prevent people from getting sick from anthrax, a potentially deadly infection spread by inhalation of spores. The response time to a biological attack is critical, the Homeland Security Department’s Susan Coller- Monarez, told the committee.
Ready to Act
“The production and dissemination of a biological agent is something the government may not be ready for, despite its best efforts, to intervene in its earliest stages,” said Coller- Monarez, who runs the threat characterization and attribution branch of the chemical and biological defense division of the Homeland Security Department.
The U.S. Postal Service is already authorized to deliver medkits to homes in the event of an anthrax attack under programs in Minneapolis and Louisville, Kentucky, that will expand to Boston, Philadelphia and San Diego. The program being discussed this week would let people obtain kits from pharmacies whenever they see fit.
FDA backing is needed before a date for rolling out the kits can be set. The Health and Human Services Department’s Biomedical Advanced Research and Development Authority, BARDA, must partner with a pharmaceutical company to guide medkit through the FDA approval process before a date for rolling out the kits could be set. Companies that make versions of doxycycline drugs include Pfizer Inc. (PFE) and Impax Laboratories Inc. (IPXL)
Sore Throats, Snowstorm
The government has tested these waters before with a study in 2007 in which the Centers for Disease Control and Prevention gave 4,182 households in the St. Louis area anthrax medkits. At the end of the study, 4,076 households were available for follow-up, 130 of those did not return their medkits.
Most who didn’t return them lost the products or threw them away while four households used them and five refused to return them, according to the report from the bioterrorism agency. One elderly woman took the doxycycline during an emergency declared for a snow storm, two used the tablets to treat sore throats and one declined to specify the use, Linda Neff, a senior epidemiologist in the CDC’s office of public health preparedness and response, said during the FDA meeting.
The kits used in the study were made by Ivax Corp., which Teva Pharmaceutical Industries Ltd. (TEVA) bought in 2006.
The Institute of Medicine, which advises the nation on health matters, recommended against broad home storage of medkits because of the potential for misuse.
Doxycycline works by preventing the growth or spread of bacteria.
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