Executive Summary

BRISTOL-MYERS SQUIBB PHASING OUT ENKAID: DEC. 16 MARKET WITHDRAWAL is announced in a Sept. 16 press statement. The company said it is providing a three-month notice so that physicians would have ample time to switch their arrhythmia patients to another therapy or to enroll their patients in an "Enkaid Continuing Patient Access Program." The continuation program is for patients who prescribers believe are well managed on encainide and should not be switched. The withdrawal could exorcise the continued political liabilities for Bristol arising from what is a relatively minor product for the company. House Human Resources and Intergovernmental Relations Subcommittee Chairman Weiss (D-N.Y.) commented on Sept. 16 that the "removal of Enkaid from the market is long overdue." The congressman said his "hearing in April documented that the FDA scientists knew that the risks of using this drug outweighed any benefits." By keeping the product available on a limited basis, the company will make other liability arguments more difficult. A major factor in the market removal, however, appears to be the approach of a new Bristol entry into the anti-arrhythmic class. The company is close to introducing the beta blocker Betapace (sotalol). With an advisory committee recommendation for approval now nine months old, the product could be ripe for final clearance from FDA by the end of the year. Bristol may well be trying to clear away some of the background noise in the anti- arrhythmic field from Enkaid to facilitate the introduction of the newer product. Bristol said it decided to withdraw encainide "based upon continuing uncertainty regarding the implications of the CAST [Cardiac Arrhythmia Suppression Trial], in addition to the availability of a growing number of alternative therapies." The company noted that the withdrawal "is not an FDA-mandated recall." Encainide is one of the three anti-arrhythmics studied in the National Heart Blood & Lung Institute's CAST study. That study was halted in May 1989 when more deaths were discovered among patients with non-life-threatening arrhythmias who were taking the drugs than those who were not taking drugs. The other products studied in the CAST trial were flecanide (3M Pharmaceuticals' Tambocor) and moricizine (Dupont Merck's Ethmozine). Neither Dupont Merck nor 3M Pharmaceuticals intends to withdraw its respective anti-arrhythmic in the near-term. Dupont Merck noted that Ethmozine was never labeled or marketed for non- life-threatening arrhythmia. 3M said that it is seeking an additional indication for Tambocor's use in superventricular arrhythmia. Bristol was unsuccessful in seeking a refractory, second-line use label for Enkaid in March of this year ("The Pink Sheet" March 18, T&G-7). Bristol-Myers Squibb said Enkaid will continue to be manufactured and will remain available free in necessary amounts "indefinitely" to patients on the drug as of Sept. 16 if their physicians believe continued treatment on Enkaid is warranted. "For such patients Bristol Laboratories will continue to provide Enkaid through their physicians," Bristol Labs Medical Department VP Edward Fox, MD, said. For patients who are switched to another product, Bristol Labs said it "is establishing a prescription reimbursement program" in which patients will be reimbursed for unused portions of Enkaid, effective immediately. The firm issued a Sept. 16 "Dear Pharmacist" letter asking that pharmacies "maintain adequate Enkaid inventory during this 90-day interim period as some patients will require additional supplies of Enkaid." The letter notes that "returns will not be accepted before Dec. 16 unless outdated or damaged." After Dec. 16, Bristol said it would reimburse pharmacies "for all existing Enkaid inventory plus shipping." The company added that it will provide a "special packet" for direct returns and asked that the product not be returned through wholesalers. A same-day "Dear Doctor" letter asks physicians to "advise your patients that they may obtain a refund by returning the unused portions of their prescriptions to pharmacies at which they were purchased." The letter tells doctors who wish to continue Enkaid treatment for certain patients to call a toll-free telephone number to "request the forms necessary to register your eligible patients in the program." Free three-month supplies of Enkaid will be shipped to doctors of patients approved for the program.