Judge Orders `Frightening' Asthma-Drug Memo To Fda

EVERETT - Calling a national pharmaceutical company's memo on the dangers of a widely used asthma drug ``really frightening,'' a Snohomish County Superior Court judge yesterday ordered the document released to the Food and Drug Administration.

``What Mr. Grigg says here is really frightening to me,'' Judge Stuart French said of a Fisons Corp. memorandum on theophylline. The drug, a muscle relaxant used to relieve upper-respiratory ailments such as asthma, can lead to seizures and death in children with viral infections.

``I don't want some kid to suffer because this was not made available to the public,'' the judge said.

The memo was written in 1985 by Cedric Grigg, Fisons' director of medical communications.

French's ruling follows last week's $6.9 million settlement between Fisons and an Everett family whose daughter, Jennifer Pollock, 6, suffered seizures and brain damage after taking Somophyllin, Fisons' brand name for the drug theophylline.

In agreeing to the settlement, the Massachusetts company didn't admit any wrongdoing.

But attorneys for the Pollocks and the girl's pediatrician, James Klicpera, contend the company hasn't made Somophyllin's dangers known to the public and the FDA, and they asked that Grigg's memo be released to prove that contention.

French declined to release the memo to anyone other than the FDA, ruling that Fisons should have a chance to submit written arguments on why it should remain confidential. After the hearing, French said the FDA may release the information in the memo to doctors.

Dr. Klicpera also has sued Fisons, saying the company's failure to adequately warn physicians about the life-threatening side effects of theophylline violates the state Consumer Protection Act and the state Product Liability Act. In addition, he alleges the company is guilty of fraudulent misrepresentation.

Fisons, however, contends it was Klicpera's errors in using the drug that caused Jennifer, suffering from a respiratory lung condition caused by her premature birth, to have seizures in 1986 that left her severely retarded. The civil suit between Klicpera and Fisons on those charges is scheduled to start May 29.

In court yesterday, Klicpera's attorney called Grigg's 1985 memo a ``smoking gun'' that showed Fisons hid important information from Klicpera until this year, when the company was compelled to disclose it under court order.

Attorneys for Fisons, however, characterized the memo as an inaccurate marketing document written to promote Intal, a drug similar to Somophyllin that doesn't have the same side effects.

Grigg ``made certain statements about theophylline that are not completely accurate,'' said attorney Guy Michelson.

Although Grigg's memo wasn't released to the public, Joel Cunningham, Klicpera's attorney, said it contained a statement that Fisons should consider halting promotion of theophylline.

He said Grigg reported an ``epidemic'' of cases in which children taking theophylline suffered serious problems such as seizures and brain damage.

Cunningham said that when children get viral illnesses, the level of theophylline in their blood can jump precipitously to toxic levels, leading to seizures and, possibly, death.

After the hearing, Michelson said experts expected to testify for Fisons, and even for Klicpera, will say no epidemic existed and that the recommended blood levels for theophylline are approved by the FDA.

He acknowledged Fisons hadn't sent warning letters about the drug's dangers to all doctors but only to about 2,000 considered ``key influential physicians.''

Michelson said the company thought reaching such influential physicians was the best way to alter all physicians' habits in using the drug.

Klicpera, however, says he didn't hear about theophylline's dangers until he received documents Fisons produced under court order in the Pollock case in March.

The Grigg memo and the letters were among 50,000-60,000 Fisons documents now kept private under court order. The warning letters, some of which also were released yesterday, include one written by Grigg in 1981 that warns of reported cases in which blood levels of theophylline jumped to toxic levels in several children when they had a viral illness.

The Klicpera lawsuit is one of three involving theophylline pending in Snohomish and King counties. The two others, both filed in King County, allege, among other things, that Key Pharmaceutical Inc. failed to notify doctors of the potential dangers of its brand of theophylline, called Theo-Dur, in children with viral illnesses.

Daniel Sullivan, an attorney in one of those cases, said he thinks Fisons' documents would show ``what the drug companies knew, when they knew it and why they didn't make it available to the medical profession.''

But Carol Lee Moody, attorney for Key Pharmaceutical, said her client warned physicians of such dangers in the late 1970s and early 1980s.