Drugmakers cheer when doctors' groups revise treatment guidelines to include new drugs. What happens when these powerful professional associations change those recommendations unfavorably? If you're AstraZeneca's MedImmune business, you fight back with sensational newspaper advertising.
As the Associated Press reports, the American Academy of Pediatrics (AAP), among the most powerful physician groups, says MedImmune's respiratory drug for premature babies, Synagis, should be used much less than it is now. Very young preemies benefit from the drug, which is designed to prevent pneumonia and other complications from respiratory syncytial virus. But few others do, the AAP says, and the group will roll out new guidelines for the drug's use on Tuesday.
In response, the AstraZeneca ($AZN) unit rolled out newspaper ads attacking the new treatment protocols, the AP reports. The ads feature a photo of a preemie hooked up to medical equipment, the news service says. "Why put these babies at risk?" the ads ask.
It's the second time in two years that the AAP has recommended limiting Synagis (palivizumab) use. The academy has been wrangling for years with recommendations for how broadly to use Synagis, particularly after a study showed that the drug reduced hospitalizations by 50%, but didn't prove that it reduced RSV-related death.
Recent sales stats show that Synagis use is declining in the U.S. but growing overseas. AstraZeneca reported $328 million in first-quarter Synagis sales, down 19% year over year, the AP notes. For all of 2013, the drug brought in almost $1.1 billion worldwide, $617 million of that in the U.S. The drug is part of an anti-infective business that AstraZeneca is considering selling off to focus on other therapeutic areas.
A MedImmune spokeswoman told the news service that the company placed full-page ads in The New York Times and several other newspapers because "we felt it important to inform parents--including the half-a-million women who give birth prematurely each year--of the decisions being made that could impact the lives of their children."
AstraZeneca isn't alone in balking at the AAP's recommendations, however. The National Perinatal Association has developed competing guidelines that limit Synagis use somewhat; older preemies shouldn't be given preventive therapy unless they have "additional risk factors," for instance. But most premature infants should have access to Synagis during RSV season if they're less than a year old when the season starts, the group advises. The National Association of Neonatal Nurses concurs.
Naturally, some mothers of babies born prematurely aren't happy with the academy's suggestions either. "Sound the Alarms--Synagis May Become Even More Limited," wrote one mother on her preemie-focused blog.
But according to the AAP, recent advances in treating premature babies make Synagis unnecessary for many of the infants who might have benefited from the drug in the past. The new guidelines say healthy preemies born after 29 weeks shouldn't be treated with Synagis. Other infants and children at risk of lung disease and other problems should be treated, however.
Synagis treatment can be costly--up to $6,000 for 5 treatments. It's designed to be administered monthly during RSV season, the drug's website notes. MedImmune has several assistance programs, including copay help for patients with insurance. The company also offers a "Cradle with Care" program with monthly text messages reminding parents to take their babies to receive their next doses.
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