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Purported AIDS Drug Got Cool Reception at FDA : ICN to Renew Fight for Ribavirin

July 12, 1987|CARLA LAZZARESCHI | Times Staff Writer

Just a few weeks ago, Milan Panic had plenty of reason to quit the race to find an AIDS treatment.

His company, ICN Pharmaceuticals, had its widely publicized anti-viral drug, ribavirin, shot down by the U.S. Food and Drug Administration. FDA Administrator Frank Young said the agency could find "no evidence of (its) effectiveness" against AIDS.

In addition, the FDA and Securities and Exchange Commission launched investigations into ICN's activities. To top it off, congressional hearings began in Washington on a variety of alleged improprieties at the Costa Mesa drug firm, including illegal sales of ribavirin to physicians.

But Panic, ICN's volatile founder and chairman, and a man who has never been accused of ducking controversy, decided to press on. A Yugoslav immigrant who pronounces his name Pahn-ish , he is gearing up for another push for ribavirin.

Panic says he is leaning toward petitioning the FDA for permission to launch a second round of tests of ribavirin on patients infected with the AIDS virus. In April, the FDA challenged the validity of ICN's first tests and denied the company's request for expanded testing. In addition to possibly working again with the FDA, Panic says, the company expects to test the drug on patients with AIDS symptoms in Canada and the United Kingdom.

"If as strong a person as I quits, then others will too," he says of ICN's efforts to win approval for ribavirin as a treatment for early stages of AIDS.

Failed to Win Approval

For Panic, the fight for ribavirin is a test of personal strength and perseverance.

"In all my mature life, I have tried to come up with a medicine to help people," he says. "I'm being crucified and I can't believe it. . . . All I can say is, 'Forgive them, God, for they know not what they do.' "

To Panic's numerous critics, such comments offer more evidence of his emotionalism and desperate need to keep the spotlight on ribavirin, the only drug the company has developed and the key to its hopes since 1972. The company's revenues primarily come from distributing ribavirin and other private-label medicines internationally.

Touted by the company during the past 15 years as a treatment for maladies ranging from the common cold to aging, ribavirin has failed to win FDA approval for all but one of its proposed uses. In late 1985, the agency cleared it as an aerosol treatment for a rare childhood respiratory infection.

The company's entry that year into the heated race to treat AIDS patients fueled suspicions that ribavirin is, in the words of one congressional investigator, "a drug which seems to have been in search of a disease."

If ICN resumes its quest for FDA approval of ribavirin, Panic and his unorthodox operating style are sure to get renewed attention. The outspoken 57-year-old already has drawn considerable fire for his optimistic--some say "promotional"--statements about the drug's powers.

Last January, the company upset the FDA and members of the medical establishment--it wasn't the first time--when Panic announced in a Washington news conference that recent tests showed that ribavirin delayed the development of AIDS in patients showing early signs of the deadly disease. Three months later, the FDA disputed the claim and put further testing of the drug on "clinical hold," an investigational limbo.

ICN's management "has not been realistic" in assessing its product, says Sarah Gordon, who follows the medical industry for the Hambrecht & Quist securities firm in San Francisco. "The other drug companies with potential AIDS drugs haven't conducted themselves this way."

Even ICN's supporters say that Panic's outbursts and courting of media attention have, at best, tarnished the company's image on Wall Street and within the industry. At worst, they say, the company's relationship with the FDA has been destroyed.

"The company has a tendency to shoot itself in the foot," says Craig Dickson, an analyst with Interstate Securities in Charlotte, N.C., and a longtime believer in ribavirin.

ICN's stock tripled in price to a peak of $34 in August, 1986, before beginning a retreat that brought it to a close of $11.75 on Friday. ICN officials say the SEC is investigating possible insider stock manipulation, insider trading and other matters; the SEC, as a matter of policy, will not comment on current investigations.

Despite the controversy that has swirled around Panic, ribavirin is getting serious consideration from some medical experts in the fight against AIDS.

Samuel Broder, head of clinical oncology for the National Cancer Institute and a leading AIDS researcher, said he believes that the drug "merits further study." Studies with the drug, separate from any sponsored by the company, are under way or planned at several research centers.

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