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UPJOHN RESPONSE TO HALCION TV CHARGES

 UPJOHN RESPONSE TO HALCION TV CHARGES
 KALAMAZOO, Mich., Dec. 16 /PRNewswire/ -- The following was released


today by The Upjohn Company (NYSE: UPJ):
 A Sunday night segment of 60 Minutes about Halcion Tablets contained numerous misleading and inaccurate statements, which raise unwarranted concerns about the safety of the product.
 Upjohn Chairman and Chief Executive Officer Theodore Cooper, M.D., Ph.D., interviewed on "60 Minutes" by reporter Ed Bradley, said today, "Upjohn's primary concern is for the patients who use Halcion and those who can benefit from it. Patients should not make decisions based on the misrepresentations contained in this program. Patients with questions about a medication should check with their physician. The physician is qualified to diagnose and treat medical problems; '60 Minutes' certainly is not. We support the doctors who prescribe Halcion," added Cooper, "and the millions of patients around the world who have benefited from it. Halcion is safe and effective when used as recommended."
 "We are concerned," said Cooper, "that the program did not contain the opinions of leading sleep experts, who could give balance to this story." Cooper characterized the broadcast segment as poor entertainment and poorer journalism, which led to several misleading impressions, several of which are addressed below.
 One such impression might be drawn from remarks of Dr. Graham Dukes, who was vice chairman of the Dutch College for the Review of Pharmaceutical Products when the College decided in 1980 to cancel the registration for Halcion in the Netherlands. Dukes told Bradley on "60 Minutes" that, in the late 1970s, the Dutch had collected reports of serious patient reactions to Halcion, many of which he said had been determined to be directly related to Halcion. Dukes has made this claim for years, but despite numerous requests, Upjohn has never been able to obtain the necessary reports from the Dutch authorities in order to analyze the data in question. Finally, it should be noted that Dukes does not purport to be a sleep expert and has never designed or conducted a clinical study for the evaluation of a drug.
 Several statements made by Dr. Anthony Kales during the program were irresponsible. He said that 50 percent of patients using Halcion in his study reported amnesia, which he misrepresented as "brain impairment." What is true is that the Halcion package insert, based on registration studies, lists amnesia at an incidence of less than 1 percent. To date, more than 250 research studies worldwide involving more than 10,000 patients, as well as seven epidemiological studies involving 23,000 patients have verified Halcion's safety and effectiveness. While Kales passes himself off as an expert on Halcion, his total published research experience with the product amounts to only 19 patients, which he has analyzed and reanalyzed, published and republished so that the 19 patients are the basis of more than 20 articles and reviews.
 One of the program's focal points was a study done on Halcion in the early 1970s, using prison volunteers. "60 Minutes" took issue with that study, Protocol 321, focusing on errors made 20 years ago by Upjohn and claiming that a significant number of severe adverse reactions occurred in the trial. The facts are these: The scientific and medical reanalysis of the study, including the omitted data, have shown there is no change in the overall risk-benefit ratio of Halcion; while Upjohn inadvertently omitted some data from the overall summary of the study, the company did provide the FDA with all individual case reports as part of the original New Drug Application, including those for patients whose data was omitted from the summary report.
 Another study questioned by "60 Minutes" was Protocol 6415, conducted in 1978-79 by Samuel I. Feurst, M.D., who was later disqualified as an investigator for falsifying data. Feurst was an outside investigator who conducted studies for a number of pharmaceutical companies, including Upjohn. When the FDA notified Upjohn and the other pharmaceutical companies that Feurst was disqualified as an investigator, Upjohn re-examined the database. Again there was no change in the risk-benefit ratio of Halcion. "60 Minutes" was also critical of an Upjohn researcher's citation of that study in a BBC-TV Panorama interview earlier this fall. The spokesperson erroneously cited the disqualified Feurst study; this was a simple mistake, not an effort to mislead.
 "Upjohn has been in business more than 100 years," Dr. Cooper said. "We intend to stay in business another hundred. When we make mistakes, we admit them and we correct them; however, when we are accused of dishonesty and lack of integrity, we are not going to stand by silently."
 The Upjohn Company 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- 12/16/91
 /CONTACT: Kaye P. Bennett, 616-323-4223, or Philip R. Sheldon, 616-323-6318, both of The Upjohn Company/
 (UPJ) CO: The Upjohn Company ST: Michigan IN: MTC SU:


ML -- DE003 -- 2364 12/16/91 08:59 EST
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Date:Dec 16, 1991
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