Pain by Keith Wailoo Page A

popularity, see “Arthritis Drug Oraflex Withdrawn from Market,”
Chicago Tribune
, August 5, 1982, 1; for Oraflex sales figures, see “Lilly Halts World Sales of Arthritis Drug, Plans $11.4 Million Charge Against Net,”
Wall Street Journal
, August 5, 1982, 4; for patient enthusiasm, see “Once a Day Arthritis Treatment Gets the Nod,”
Atlanta Daily World
, May 9, 1982, 5.
    10 . For problems with Oraflex, see “Arthritis Drug Oraflex Withdrawn from Market,” 1; “At Least Eight Deaths Tied to Arthritis Drug,”
Baltimore Sun
, July 31, 1982, A5; for impact on the company, see “Lilly Halts World Sales of Arthritis Drug,” 4; “Lilly Says Grand Jury Now Is Investigating Firm’s Oraflex Drug,”
Wall Street Journal
, April 24, 1984, 49.
    11 . For Lilly’s argument, see “Lilly Halts World Sales of Arthritis Drug,” 4; for “out of fear …,” see “U.S. Toughens Plan for Quicker Review of Drug Products,”
Wall Street Journal
, October 19, 1982, 12.
    12 . “U.S. Refused to Prosecute Lilly Officials,”
Baltimore Sun
, August 29, 1985, 19A; for Conyers, see Philip Shenon, “U.S. Is Said to Have Dropped Three Officials from Lilly Case,”
New York Times
, August 29, 1985, A20.
    13 . For Democrats’ charge, see “Justice Department Defends Handling of Lilly Case,”
Los Angeles Times
, September 12 1985, D4; for “the agency’s need …,” see Morton Mintz, “Drug Approval Hit,”
Washington Post
, July 21, 1987, H6. Zomax had been withdrawn from the market in the spring of 1983, and congressional hearings had found that while the FDA had received reports of more than two thousand allergic reactions, key officials at the agency failed to act because they remained unaware of those reports. As a 1985
New York Times
editorial concluded, “The prescriptions for avoiding more Oraflex scandals are obvious enough … The FDA must be tougher in insisting on getting the data it needs to protect the public. As for the Justice Department, its failure to prosecute the case its staff lawyers had built is a disservice to the drug industry, the FDA’sreporting system and the public.” “Arthritis at the Justice Department,”
New York Times
, September 14, 1985, 22.
    14 . For Toradol concerns, see C. J. Pearce, F. M. Gonzalez, and J. D. Wallin, “Renal Failure and Hyperkalemia Associated with Ketorolac Tromethamine,”
Archives of Internal Medicine
153, no. 8 (April 26, 1993): 1000–1002; R. P. Murray and R. C. Watson, “Acute Renal Failure and Gastrointestinal Bleed Associated with Postoperative Toradol and Vancomycin,”
Orthopedics
16, no. 12 (December 1993): 1361–63; for “anti-arthritis wonder drug,” see Morton Mintz, “Arthritis Drug Naprosyn May Be Taken off Market,”
Washington Post
, September 13, 1976, A8; for increasing concerns over Toradol, see T. L. Yarboro Sr., “Intramuscular Toradol, Gastrointestinal Bleeding, and Peptic Ulcer Perforation: A Case Report,”
Journal of the National Medical Association
87, no. 3 (March 1995): 225–27. In 1996,
JAMA
published a study that revealed significantly increased risk of bleeding after use of Toradol at high doses or after prolonged use. Brian Strom et al., “Parenteral Ketorolac and Risk of Gastrointestinal and Operative Site Bleeding: A Postmarketing Surveillance Study,”
Journal of the American Medical Association
275 (1996): 376–82; see also Luis Alberto Garcia Rodriguez, “Risk of Hospitalization for Upper Gastrointestinal Tract Bleeding Associated with Keterolac, Other Nonsteroidal Anti-Inflammatory Drugs, Calcium Antagonists, and Other Antihypertensive Drugs,”
Archives of Internal Medicine
158 (1998): 33–39.
    15 . For industry profit speculation, see N. R. Kleinfeld, “Arthritis: Building an Industry on Pain,”
New York Times
, August 18, 1985,