Rezulin: Anatomy of a ‘Billion-Dollar Blockbuster’
1996
June: The National Institutes of Health launches a $150-million experiment, testing whether Rezulin or another drug can prevent adult-onset diabetes.
July 31: Warner-Lambert Co. applies to the Food and Drug Administration for approval of Rezulin as a prescription drug.
Oct. 9: A veteran FDA medical officer recommends rejecting Rezulin, citing potential danger to the liver and heart as well as doubts about the drug’s effectiveness.
Nov. 4: The FDA medical officer is removed from his months-long examination of Rezulin after complaints from Warner-Lambert executives.
Dec. 2: Warmer-Lambert forms a joint venture with Sankyo Co. to sell Rezulin in the United States.
Dec. 11: The FDA official who takes over the review of Rezulin vouches for the drug’s effectiveness and downplays safety risks.
1997
Jan. 29: FDA approves Rezulin as a new prescription drug for Type 2 diabetics already taking insulin shots.
Feb. 24: A regulatory review officer at FDA advises Warner-Lambert to “immediately discontinue” its “false and misleading promotional claims about Rezulin.
March: Warner-Lambert begins selling Rezulin in the United States.
May 5: The chairman of Warner-Lambert tells investors that Rezulin and another drug “have the potential to be billion-dollar blockbusters.”
Aug. 4: Warner-Lambert announces that Rezulin has received clearance by the FDA for broader use.
August: Rezulin is approved for use in Britain.
October: Warner-Lambert’s stock price doubles from the preceding year and is up four times over 1994. Analysts attribute the company’s surge to sales of Rezulin and a cholesterol-lowering drug.
Oct. 28: Warner-Lambert sends a “Dear Doctor” letter to health care professionals, notifying them of “rare reports of liver problems” in patients using Rezulin.
Nov. 3: FDA issues a “talk paper” revealing that one death and one liver transplant are linked to Rezulin. The FDA and Warner-Lambert both recommend the routine checking of patients’ liver functions.
Nov. 12: An FDA diabetes specialist notifies his superiors that it is “reasonable” to estimate that 12,350 people using Rezulin would experience liver injury. He estimated that, without liver-function monitoring, 2,000 people would suffer toxicity at what can be life-threatening levels.
Dec. 1: Rezulin is withdrawn from Britain because of safety concerns, triggering an 18.5% plunge in Warner-Lambert’s price on the New York Stock Exchange. The drug remains available in the United States.
Another FDA “talk paper” cites three additional liver-failure deaths. The agency advises that patients taking Rezulin “should be monitored more frequently” but adds: “At present the agency continues to find the benefits outweigh the risks.”
1998
April 28: Warner-Lambert announes that its first-quarter profit rose 37%, compared with 1997, fueled by sales of Rezulin and a cholesterol-lowering drug. “This was the best quarter ever for this company,” the CEO tells shareholders.
May 17: A high school teacher taking Rezulin in the national diabetes-prevention experiment dies after liver failure and a transplant. Officials quickly banish the drug from the National Institutes of Health study.
July 28: Warner-Lambert issues another “Dear Doctor” letter to health care providers, detailing new liver-monitoring recommendations for Rezulin.
Oct. 19: Warner-Lambert reports that third-quarter earnings soar 49% over the previous year. Sales of Rezulin for the quarter were $181 million, an increase of 32%.
Dec. 4: FDA discloses to The Times that at least 33 deaths are linked to use of Rezulin.
Researched by JANET LUNDBLAD / Los Angeles Times
Sources: FDA, SEC, press releases, Times reporting
