Marketing Fear
Nathan Vardi
Forbes.com
Thomas Handel has a tough assignment. The executive for the Meridian unit of King Pharmaceuticals is trying to figure out how to be first to sell a counter-terrorism prescription drug directly to consumers--without looking shameless. "This is an issue of an unmet need," he says cautiously. "But terrorism raises an emotional trigger, so we need to be careful."
Handel's product is AtroPen, an antidote for nerve gas agents like VX or Sarin, which if released into the ventilation system of three large U.S. office buildings would kill 6,000, according to a U.S. Department of Homeland Security report on the top 15 terror threats that surfaced in March.
Nerve agents stop the body from breaking down the acetylcholine neurotransmitter, overwhelming the nervous system and causing convulsions that can lead to death within minutes of exposure. The drug atropine allows the body to manage the excess acetylcholine, and the AtroPen injection device that can deliver it has been used by the U.S. Department of Defense since 1959. King's Meridian unit had $123 million in revenue for 2004.
But getting doctors to fill AtroPen prescriptions for civilians is an idea that makes many nervous. "I am totally against this, it's bordering on irresponsible," says Chicago toxicologist Steven Aks. "There is a lot of fear-mongering going on."
About a quarter of the physicians have expressed deep concern about potential misuse of consumer AtroPen at several focus groups run by Michael Allswede, senior associate at University of Pittsburgh's Center for Biosecurity. "Physicians are concerned people will smell gas, pull out their AtroPen and start treating themselves," says Allswede.
Nevertheless, King (nyse: KG - news - people ) thinks it can duplicate Meridian's success with EpiPen, the injector that administers the epinephrine treatment for severe allergic reactions and is carried around by those at risk of getting potentially fatal allergic reactions. King got U.S. Food and Drug Administration approval in 2003 for pediatric doses of AtroPen and new labeling and packaging for consumers, as opposed to then-existing military labels. Another infant dose was approved last year.
To get the approvals, King promised verbally not to promote AtroPen until the FDA's neuropharmacological drug products division had a chance to assess the policy implications of distributing counter-terror drugs and look at and comment on the AtroPen marketing materials. Normally after a drug is approved, companies provide promotional materials to only the FDA's drug marketing division, which verifies compliance rather than grants approval.
King submitted to the FDA its publicity plans, which for now include its AtroPen.com Web site, medical journal ads and training brochure, in August 2004 and is still waiting to hear from the government. Meanwhile, two-thirds of the 25 pharmacy benefit managers and managed care reps interviewed by a consultant late last year said their firms would be willing to provide some level of reimbursement for AtroPen, depending on the circumstances.
King is convinced AtroPen poses little public health risk, but the evidence cuts both ways. A study of 268 children injected with atropine when Saddam Hussein lobbed Scud missiles into Israel during the 1991 Gulf War found no fatalities or seizures. But the fact that the kids got injections despite the absence of a nerve gas attack does not sit well with critics who don't view Israel's tiny and military trained population as a good comparison group to U.S. civilians.
"There are incompetent people, and the device shoots a needle so you can puncture something," concedes Allswede, who supports King's effort because he is concerned that U.S. federal and local emergency management services are currently not able to deliver stockpiled AtroPen fast enough to an exposed area. An unpublished late 2003 Internet poll conducted by the National Association of Emergency Medical Technicians had 92% of EMS workers responding that they did not have AtroPen in their vehicles.
Other outfits developing counter-terror drugs are watching the AtroPen precedent closely.
So far the only commercially available drugs that have a biological or chemical anti-terror purpose are over-the-counter potassium iodide pills sold as a long-term radiation treatment, and Bayer's (nyse: BAY - news - people ) Cipro, an antibiotic that can be used to prevent anthrax toxicity. Neither would be of much immediate use to the direct victims of a biological or nuclear attack.
Says Robert Marsella, a vice president at Hollis-Eden Pharmaceuticals (nasdaq: HEPH - news - people ), a San Diego company hoping to get FDA approval for its nuclear attack antidote in 2006, "We believe there is going to be a consumer market for this kind of protection."
Nathan Vardi
Forbes.com
Thomas Handel has a tough assignment. The executive for the Meridian unit of King Pharmaceuticals is trying to figure out how to be first to sell a counter-terrorism prescription drug directly to consumers--without looking shameless. "This is an issue of an unmet need," he says cautiously. "But terrorism raises an emotional trigger, so we need to be careful."
Handel's product is AtroPen, an antidote for nerve gas agents like VX or Sarin, which if released into the ventilation system of three large U.S. office buildings would kill 6,000, according to a U.S. Department of Homeland Security report on the top 15 terror threats that surfaced in March.
Nerve agents stop the body from breaking down the acetylcholine neurotransmitter, overwhelming the nervous system and causing convulsions that can lead to death within minutes of exposure. The drug atropine allows the body to manage the excess acetylcholine, and the AtroPen injection device that can deliver it has been used by the U.S. Department of Defense since 1959. King's Meridian unit had $123 million in revenue for 2004.
But getting doctors to fill AtroPen prescriptions for civilians is an idea that makes many nervous. "I am totally against this, it's bordering on irresponsible," says Chicago toxicologist Steven Aks. "There is a lot of fear-mongering going on."
About a quarter of the physicians have expressed deep concern about potential misuse of consumer AtroPen at several focus groups run by Michael Allswede, senior associate at University of Pittsburgh's Center for Biosecurity. "Physicians are concerned people will smell gas, pull out their AtroPen and start treating themselves," says Allswede.
Nevertheless, King (nyse: KG - news - people ) thinks it can duplicate Meridian's success with EpiPen, the injector that administers the epinephrine treatment for severe allergic reactions and is carried around by those at risk of getting potentially fatal allergic reactions. King got U.S. Food and Drug Administration approval in 2003 for pediatric doses of AtroPen and new labeling and packaging for consumers, as opposed to then-existing military labels. Another infant dose was approved last year.
To get the approvals, King promised verbally not to promote AtroPen until the FDA's neuropharmacological drug products division had a chance to assess the policy implications of distributing counter-terror drugs and look at and comment on the AtroPen marketing materials. Normally after a drug is approved, companies provide promotional materials to only the FDA's drug marketing division, which verifies compliance rather than grants approval.
King submitted to the FDA its publicity plans, which for now include its AtroPen.com Web site, medical journal ads and training brochure, in August 2004 and is still waiting to hear from the government. Meanwhile, two-thirds of the 25 pharmacy benefit managers and managed care reps interviewed by a consultant late last year said their firms would be willing to provide some level of reimbursement for AtroPen, depending on the circumstances.
King is convinced AtroPen poses little public health risk, but the evidence cuts both ways. A study of 268 children injected with atropine when Saddam Hussein lobbed Scud missiles into Israel during the 1991 Gulf War found no fatalities or seizures. But the fact that the kids got injections despite the absence of a nerve gas attack does not sit well with critics who don't view Israel's tiny and military trained population as a good comparison group to U.S. civilians.
"There are incompetent people, and the device shoots a needle so you can puncture something," concedes Allswede, who supports King's effort because he is concerned that U.S. federal and local emergency management services are currently not able to deliver stockpiled AtroPen fast enough to an exposed area. An unpublished late 2003 Internet poll conducted by the National Association of Emergency Medical Technicians had 92% of EMS workers responding that they did not have AtroPen in their vehicles.
Other outfits developing counter-terror drugs are watching the AtroPen precedent closely.
So far the only commercially available drugs that have a biological or chemical anti-terror purpose are over-the-counter potassium iodide pills sold as a long-term radiation treatment, and Bayer's (nyse: BAY - news - people ) Cipro, an antibiotic that can be used to prevent anthrax toxicity. Neither would be of much immediate use to the direct victims of a biological or nuclear attack.
Says Robert Marsella, a vice president at Hollis-Eden Pharmaceuticals (nasdaq: HEPH - news - people ), a San Diego company hoping to get FDA approval for its nuclear attack antidote in 2006, "We believe there is going to be a consumer market for this kind of protection."
