Drug Firm Denies It Hid Data -- Doctor Says He Didn't Receive Effects Warning

Fisons Corp., on trial for allegedly concealing information about an asthma drug's side effects, had no reason to hide the medication's dangers, a Fisons executive testified yesterday.

``We'd want it to be known,'' said Bruce Simpson, senior vice president for sales and marketing.

He said the company's primary product, which also treats asthma, doesn't have the same problem.

But Simpson also testified that the national pharmaceutical company notified only a select number of specialists about studies that reported some of the dangerous side effects of Somophyllin, Fisons' brand name for the generic drug theophylline.

Those selected physicians, not including anyone in Snohomish County, were doctors Fisons had targeted as potential customers for Intal, a patented Fisons asthma medication, Simpson said.

Simpson was the third witness called in a trial in Snohomish County Superior Court where Fisons Corp. is defending itself against an Everett doctor who has sued the company.

The doctor says the company failed to adequately warn most physicians that standard doses of theophylline given to people, especially children, with viral illnesses can lead to seizures, even death.

In 1986, the doctor, James Klicpera, treated 2-year-old Jennifer Pollock with Somophyllin for a serious lung condition when she had a fever and viral infection. The drug is a muscle relaxant that's widely used to treat asthma and other bronchial ailments.

Pollock had seizures less than two days later, which led her to become severely retarded.

Without admitting wrongdoing, Fisons, which has its corporate headquarters in Rochester, N.Y., last month reached a $6.9 million out-of-court settlement with the Pollock family.

Klicpera, whom the family also named in their lawsuit, earlier agreed to pay the family an additional $500,000 if a settlement was reached. But he later decided to sue the company, saying documents uncovered while preparing for trial showed Fisons had information it should have passed on to non-specialists such as himself.

The Food and Drug Administration requires drug companies to state that doctors should reduce and closely monitor theophylline doses when someone has a fever. It does not require any warnings about viral illnesses.

Simpson testified yesterday that marketing documents presented in court overemphasized pieces of the medical literature that Fisons used to denigrate theophylline products and promote Intal. He also said Cedric Grigg, the author of the memos, was overzealous in marketing Intal. He said Grigg's responsibility is to sell Intal by ``overemphasizing to the KIPs (key influential physicians)'' studies critical of theophylline.

Patrick Sheldon, one of Klicpera's attorneys, asked Simpson to read parts of dozens of Intal marketing memos and letters that highlighted dangers of theophylline not reflected in the instructions the company includes with its theophylline products.

After the day's testimony, Sheldon said the documents show a 12-year history of how Fisons criticized theophylline to some physicians, yet promoted it to others.