CHICAGO – A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine.
The dispute involves new guidelines from the American Academy of Pediatrics, which said medical evidence shows the drug benefits few children other than very young preemies. The medicine guards against a common but usually mild virus that can cause serious lung problems.
It's the second time in two years that the influential group has recommended narrowing use of the drug, sold by MedImmune under the brand name Synagis. MedImmune is fighting back with full-page newspaper ads that say the updated policy threatens "our most vulnerable babies."
Synagis protects against RSV, or respiratory syncytial virus, which infects nearly all U.S. children by the age of 2. For most, it causes only mild, cold-like symptoms. But it is also the most common cause of pneumonia in U.S. infants, and as many as 125,000 young children are hospitalized with RSV each year, according to the federal Centers for Disease Control and Prevention.
It was approved in 1998 for use in certain "high-risk" children, based on research showing benefits for certain children including premature infants born at 35 weeks or earlier. The pediatricians' group says it has sought to provide more specific guidance because the government's definition of high risk is vague.
The medicine is given in a series of seasonal injections costing thousands of dollars, and a recent lag in Synagis sales may explain MedImmune's tactics, which include recruiting parents to help tout the drug.
Sales for the first quarter of 2014 totaled $328 million, down 19 percent from $414 million in the same period last year, according to an earnings report from parent company AstraZeneca.
Company spokeswoman Alisha Martin said it 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."
Studies show the drug can slightly reduce risks for being hospitalized but doesn't shorten hospital stays or lessen chances for long-term complications or death, said Dr. H. Cody Meissner, a member of an academy committee involved in drafting the new guidance and an infectious disease expert at Tufts Medical Center.
Advances in treatment for preemies in recent years make Synagis, also known as palivizumab, unnecessary for many, the academy says. Its new guidance recommends it only for: infants born before 29 weeks; older preemies with chronic lung disease and those with certain heart problems; and certain other at-risk children younger than age 2.
Healthy older preemies should not get the drug, the academy says in guidelines published online Monday. Its 2012 advice included use in some older, healthy preemies.
Melony Sorbero, a senior Rand Corp. researcher, has studied RSV said the academy's narrowed recommendations make sense based on scientific evidence of limited benefits.
MedImmune's newspaper ads said the new guidelines will leave about 140,000 infants born between 29 and 35 weeks "unprotected." The ads said: "Why put these babies at risk?" They include a photo of a tiny preemie hooked up to medical machinery.
A Washington, DC-area mother, Deb Discenza, has helped the drugmaker locate parents to participate in a MedImmune RSV awareness program and said she was paid for sharing information about her daughter's experience. Her daughter was born at 30 weeks, or about two months early, in 2003. The baby may not have qualified for the medicine under the academy's new guidance but her mother believes Synagis treatment that first year "is what saved us."
The little girl's doctor declined to offer the drug after she turned 1, and she developed asthma. Discenza believes Synagis might have prevented it.
She said her health insurance covered the shots, but she's among parents who worry coverage will be denied based on the new recommendations.
Susan Pisano, spokeswoman for the industry group America's Health Insurance Plans, says insurers consider medical groups' recommendations but that it's too soon to determine if the pediatricians' new advice will affect coverage decisions.