Inhalers, immunizations, and increases

September 1, 2007

Asthma inhalers, pediatric vaccination, and government funding of children's health insurance are the talk of the town this month.

Should CFC-released asthma inhalers be banned?

In an action that could ban an inhalant some specialists call critical to a subset of pediatric asthma patients, the Food and Drug Administration (FDA) proposed to prohibit seven medications because they contain chlorofluorocarbons (CFCs).

CFCs usage has generally been prohibited since the 1970s because they cause thinning of the ozone. FDA still allows some "essential" uses, but is proposing taking the designation away from seven inhalants-including Maxair, prescribed for many children-by the end of 2009. That means if manufacturers can't reformulate by then, the products will be off the market.

Witnesses at the FDA meeting pointed out that Maxair is the only pirbuterol metered-dose inhaler and the only breath-actuated rescue inhaler. James Lee, MD, chief medical officer of Graceway Pharmaceuticals, which makes Maxair, said over a quarter million patients use it.

Marc Boguniewicz, MD, who specializes in pediatric asthma, told the FDA panel that asthma is a far more complicated disease than previously thought. There are subtypes of the disease, and patients respond differently to different medications.

Michael Wechsler, MD, a Harvard Medical School teacher and asthma researcher, said he prescribes a generic version of albuterol to most patients: "But it does not work in everybody." For both short-acting and long-acting beta agonists, "there are responders and nonresponders," he said.

In addition, with the breath-actuated device, there is no need for coordination and the training is minimal, he said. Poor technique often sends the medication "anywhere but in their airways ... While these devices seem somewhat simple, there are instances where you need to really have a simple device that can only be worked one way."

Asthma specialist Clifford Bassett, MD, said that studies have shown that most patients "may actuate their metered dose inhaler either too early or too late during the respiratory cycle and a breath-actuated device could potentially reduce or eliminate this difficult step." That makes Maxair's unique delivery system worthy of consideration until a non-CFC propellant is introduced, he said

"Pirbuterol is a different molecule," he added. "It is my perception in some cases that patients have adverse reactions when they use an albuterol product as a rescue inhaler, whether it be tachycardia or nervousness." Even though asthma is a treatable disease, people still die of it.

Robert Meyer, MD, director of the FDA's Office of Drug Evaluation II and chair of the FDA panel listening to the comments, noted that CFC manufacturers are phasing out of the business around the world in the next few years. That gives Graceway limited time to reformulate, in any case.

Graceway's Lee responded that the company is working against that time pressure also, but it knows it cannot reformulate before the FDA plan would remove it from the market. Formed last year, Graceway bought Maxair from 3M last December.

Documents on this issue are in the June 11 Federal Register ( http://www.gpoaccess.gov/) and in the FDA docket (2006N-0454) http://www.fda.gov/ohrms/dockets. Comments may be submitted through September 10.

The growing immunization loophole

The holes in coverage for children's immunizations are stretching wider, say advocates working on the issue.

For pediatricians, that can mean more instances of being unable to afford to give all children all their immunizations, not knowing whether doctors can get the vaccines, or being uncertain whether children will get any or all immunizations if they go to a health department or public clinic.