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Court Bars ICN Claims of Drug to Slow AIDS : Pharmaceuticals: The Costa Mesa drug maker is accused of fraud in its effort to win federal approval of a drug it said could delay onset of the disease.

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From Associated Press

A federal judge Monday approved a consent order against a California pharmaceutical company accused of fraud in its effort to win federal approval of a drug it said could slow the onset of AIDS.

ICN Pharmaceuticals Inc. of Costa Mesa, and its subsidiary, Viratek Inc., admitted no wrongdoing in accepting the injunction that bars it from using false information in its business or filing false reports with the Securities and Exchange Commission.

The order, approved by U.S. District Judge Gerhard A. Gesell, also requires the company to comply with the law on reporting its acquisition of securities.

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The case concerns ICN’s drug, ribavirin, which has received Food and Drug Administration approval only for use to treat infants hospitalized for a serious respiratory infection.

In 1986, ICN conducted clinical tests of the drug on patients infected with the AIDS virus.

According to the SEC’s complaint, ICN changed the focus of one of its clinical tests when officials found the initial goals--inhibition of the AIDS virus and improvement of the body’s immune system--were not being achieved.

The study did find evidence that fewer of the patients being given the drug were progressing to cases of full-blown AIDS. The study was changed to focus on that issue, according to the SEC, despite FDA warnings that the tests were insufficient to show the drug’s effectiveness in such cases.

Ignoring admonitions from the FDA not to make its test data public pending further analysis, the company held a news conference in January, 1987, to say the tests showed ribavirin was effective in keeping AIDS-infected patients with weakened immune systems from developing full-blown AIDS.

In April, 1987, the FDA refused to approve the company’s request to make the drug more widely available for further testing on AIDS patients.

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The SEC contended that the company used fraud in connection with the sale of securities, filed a false report with the SEC and failed to disclose by the legal deadline its acquisition of additional shares of Viratek stock.

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