Copyright 2005 by Katherine Eban
For information about permission to reproduce selections from this book, write to or to Permissions, Houghton Mifflin Harcourt Publishing Company, 3 Park Avenue, 19th Floor, New York, New York 10016.
www.hmhco.com
A Counterfeita Plated Person reprinted by the permission of the publishers and the Trustees of Amherst College from The Poems of Emily Dickinson, Thomas H Johnson, ed, Cambridge, Mass : The Belknap Press of Harvard University Press, Copyright 1951, 1955, 1979, 1983 by the President and Fellows of Harvard College.
The Library of Congress has cataloged the hardcover edition as follows:
Eban, Katherine.
Dangerous doses how counterfeiters are contaminating Americas drug supply/Katherine Eban.1st ed.
p. cm.
1. Pharmaceutical policyUnited States. 2. Drug adulteration. 3. DrugsSafety measures. 4. Product counterfeiting. [DNLM 1. FraudUnited States. 2. Pharmaceutical Preparationssupply & distributionUnited States. 3. Consumer AdvocacyUnited States. 4. Government RegulationUnited States. 5. Legislation, DrugUnited States. QV 736 E15d 2005] I. Title.
RA401A3E25 2005
363 19'4dc22 2004025581
ISBN -13: 978-0-15-101050-9 ISBN -10: 0-15-101050-1
ISBN -13: 978-0-15-603085-4 (pbk.) ISBN -10: 0-15-603085-3 (pbk.)
e ISBN 978-0-547-53853-2
v2.0717
For my beloved friend Karen Avenoso (19671998)
Whom I admire and miss every day
A Note to Readers
D ANGEROUS D OSES IS BASED ON TWO-AND-A-HALF YEARS OF reporting in which I conducted more than 160 significant interviews with people involved in the problem of contaminated medicine in America. Those I interviewed include government investigators, pharmacists, doctors, patients, drug makers, lobbyists, politicians, regulators, lawyers, researchers, and pharmaceutical wholesalers, as well as those involved in drug counterfeiting and diversion. I also conducted dozens of background interviews with sources that asked not to be named but whose contributions helped to shape the book.
In the course of this reporting, I obtained more than 13,000 pages of documents. These include government records received in response to sixteen Freedom of Information requests I submitted to the Food and Drug Administration, the Florida health department, the Florida Department of Law Enforcement, and other state pharmacy boards. Wherever possible, I have relied on original material including internal memorandums, police reports, sales records, shipping records, correspondence, investigative records, inspection reports, search warrants, surveillance videotapes, photographs, and court documents. This material includes the investigative records from Operation Stone Cold of both the Florida Department of Law Enforcement and the Miami-Dade Police Department.
My reporting has benefited from the extensive help of federal and state law-enforcement officials, including members of the Operation Stone Cold task force. In the books endnotes, the reader will find references to documents I used to re-create scenes and make factual assertions. Material that came from interviews and events that I reported firsthand is not cited in endnotes. Instead, after the endnotes, I have provided a list of substantive on-the-record interviews I conducted for the book. I have not included the names of the hundreds of people I interviewed whose information did not directly shape the narrative.
I made sixteen trips to Florida, as well as trips to Nevada, Missouri, Tennessee, Georgia, and Washington, D.C. Scenes I did not witness were re-created through interviews with those present as well as through investigative records, transcripts, audiotapes, and videotapes. I worked to resolve discrepancies through repeated interviews with as many of those present as possible. The few instances where discrepancies remain are documented in endnotes. In drawing on investigative reports, I did my best to independently confirm the information contained in them.
Each of those persons or companies described in this book as being involved in potentially criminal or other unlawful activity was given an opportunity to comment, respond to allegations, or correct the record, either firsthand or through their lawyers. Readers should keep in mind that, except as expressly stated otherwise in the text or endnotes: At the time this book went to press none had been determined to have violated any criminal or other laws; all have, or should be considered to have, denied any wrongdoing; and each of those indicted has pleaded not guilty. All should be deemed innocent of any accusations of unlawful activity unless and until proved otherwise in the final outcome of judicial proceedings. Readers are encouraged to consult the Whos Who immediately following and the endnotes.
Winter 2004/2005
Whos Who
FLORIDA
Operation Stone Cold
HORSEMEN OF THE APOCALYPSE Five investigators who penetrated the corruption of Americas drug supply.
Cesar Arias, Drug Inspector, Bureau of Statewide Pharmaceutical Services
Gene Odin, Drug Inspector, Bureau of Statewide Pharmaceutical Services
Randy Jones, former Detective, Miami-Dade Police Department
John Petri, Sergeant, Miami-Dade Police Department
Gary Venema, Special Agent, Florida Department of Law Enforcement
SUPPORTING INVESTIGATORS
Jack Calvar, Senior Investigator, Medicaid Fraud Control Unit, Attorney Generals Office
Steve Zimmerman, Detective, Miami-Dade Police Department
CATALYSTS OF THE INVESTIGATION
Martin J. Bradley, CEO & Founding Partner, BioMed Plus, Miami
Sydney Dean Jones, pharmacy technician; cooperating witness
Annette Mantia, former secondary wholesaler; cooperating witness
Government
DEPARTMENT OF HEALTH
Dr. John O. Agwunobi, Secretary
Robert Daniti, General Counsel
Jerry Hill, Chief, Bureau of Statewide Pharmaceutical Services
Gregg Jones, Pharmaceutical Program Manager, Bureau of Statewide Pharmaceutical Services
Sandra Stovall, Compliance Officer, Bureau of Statewide Pharmaceutical Services
Robert Loudis, former Drug Inspector, Bureau of Statewide Pharmaceutical Services
ATTORNEY GENERALS OFFICE
Charlie Crist, Attorney General
Peter Williams, Statewide Prosecutor
Melanie Ann Hines, former Statewide Prosecutor
Oscar Gelpi, Assistant Statewide Prosecutor
Stephanie Feldman, former Assistant Statewide Prosecutor
Robert Penezic, former Assistant Statewide Prosecutor
FLORIDA DEPARTMENT OF LAW ENFORCEMENT
Michael Mann, Assistant Special Agent in Charge
Tim Moore, former Commissioner
HOUSE OF REPRESENTATIVES
Representative Ed Homan (R-Temple Terrace)
STATE SENATE
Senator Walter Skip Campbell Jr. (D-Tamarac)
FEDERAL
Food & Drug Administration
OFFICE OF THE COMMISSIONER
William Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation
OFFICE OF CRIMINAL INVESTIGATIONS
Terrell L. Vermillion, Director
Luis Perez, Special Agent, Miami Field Office
Doug Fabel, former Special Agent in Charge, Miami Field Office
Kent Walker, former Special Agent in Charge, Miami Field Office
U.S. House of Representatives
Congressman John Dingell (D-MI)
Congressman Steve Israel (D-NY)
PATIENTS
Counterfeit Epogen
Timothy Fagan, sixteen-year-old New York transplant patient
Kevin Fagan, father
Jeanne Fagan, mother
Dr. Lewis Teperman, Director of Transplantation, New York University Medical Center
Eric Turkewitz, family lawyer
Counterfeit Procrit
Next page