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UPJOHN RESPONDS TO WOLFE FDA LETTER

 KALAMAZOO, Mich., June 11 /PRNewswire/ -- Responding to media coverage today which reports a letter sent yesterday by Sidney Wolfe to U.S. Food and Drug Commissioner David Kessler, Ley S. Smith, President and Chief Operating Officer of The Upjohn Company, said, "We are appalled by the misleading information being presented to the American public by Dr. Wolfe. Based on his letter, we have sent the following to Dr. Kessler."
 Dear Dr. Kessler:
 We have obtained a copy of the letter sent to you yesterday by Sidney Wolfe, accusing the Food and Drug Administration of "inexcusable" behavior for not banning the sleeping medication Halcion in the United States. Dr. Wolfe's letter follows the revocation of the Halcion license in the U.K., despite the advice and recommendation by two government-appointed expert committees that the product should be available to patients in that country.
 In slandering this product, Dr. Wolfe spins an interesting story, but, as usual it is only half the story and perhaps, in this case, even less than half. For example he neglects to mention that the report of the Appointed Persons Panel (a group of five, not one, as he erroneously asserts), named by the Minister of Health to review the scientific issues regarding Halcion, was strongly supportive of the safety of Halcion and found that its side effect profile is comparable to -- and in some ways preferable to -- that of other benzodiazepine hypnotics. I have attached a copy of that report for your information, since I am confident that Dr. Wolfe will not call it to your attention. This report, submitted by the Appointed Persons Panel to the Licensing Authority in April 1993, was omitted from Dr. Wolfe's chronology of events.
 Dr. Wolfe has a long history of distorting the facts about Halcion, demonstrating this in his remarks at the FDA Advisory Committee meeting in May 1992 (where his charges were rejected by the vote of the Committee) and in various petitions to your agency, each of which has been fraught with inaccuracies and inconsistencies.
 Dr. Wolfe's letter cites "new information" from a July 1992 U.K. government letter to Upjohn. This is patently untrue and deliberately misleading. All of the information in that letter was widely available a year ago; it was publicly discussed at that time and since, both by Upjohn and the Licensing Authority.
 You know as well as we do, Dr. Kessler, that the FDA is in the majority in its actions regarding Halcion. More than 80 countries around the world continue to make it available to patients; in a score of other countries and in the Committee on Proprietary Medicinal Products in the European Community, scientific reviews have reassured regulators about its safety. Two countries, Finland and Jamaica, which initially suspended the drug in reaction to the U.K.'s action, have since reinstated it. It is the U.K. which is outside the generally accepted position of the rest of the world.
 The real puzzle is not, as Dr. Wolfe implies, why the FDA has chosen to listen to its Advisory Committee, to heed the facts and to continue to make Halcion available in the U.S. The more germane question is why the U.K. regulators have ignored the findings of their own advisors and the weight of scientific evidence. We're convinced that the U.K. decision is an example of a hasty regulatory action based on incomplete information and a refusal to reverse that decision and admit a mistake, even in light of the facts.
 Dr. Wolfe consistently uses the media to attempt to stir emotions and outrage in the course of his various vendettas against the pharmaceutical industry and a host of its products. Cloaking himself in the guise of public interest, he places politics above science and truth. We suggest that this is what is inexcusable.
 Thank you.
 Ley S. Smith
 President and Chief Operating Officer
 The Upjohn Company (NYSE: UPJ) is a worldwide, research-based provider of human health care products, animal health products, agronomic and vegetable seeds and specialty chemicals. Headquartered in Kalamazoo, the company has been dedicated to improving health and nutrition for more than a century.
 -0- 6/11/93
 /CONTACT: Kaye Bennett of The Upjohn Company, 616-323-4224/
 (UPJ)


CO: The Upjohn Company ST: Michigan IN: MTC SU:

ML -- DE028 -- 4509 06/11/93 15:07 EDT
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Date:Jun 11, 1993
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