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Alicia Mundy - Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen

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Alicia Mundy Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen
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Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen: summary, description and annotation

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Semi-finalist for the Robert F. Kennedy Memorial Book Award
In 1996, a terrible epidemic began killing young American women. Some died quickly, literally dropping in their steps. Others took more time, from a few months to a few years. Those who werent killed suffered damage to their lungs and hearts, much of it permanent and reparable only with major surgery. Doctors suspected what the killer was. So did the Food and Drug Administration. The culprits were the two most popular diet drugs in the United States, Pondimin, one-half of the popular drug combination Fen-Phen, and Redux, a stronger version of Pondimin. They were also two of the most profitable drugs on the market, and both were produced and sold by a powerful pharmaceutical company, Wyeth-Ayerst, a division of American Home Products.
Dispensing the Truth is the gripping storry of what the drug really knew about its drugs, the ways it kept this information from the public, doctors, and FDA, and the massive legal battles that ensued as victims and their attorneys searched for the truth behind the debacle.
It tells the story of a healthy young woman, Mary Linnen, who took the drugs for only twenty-three days to lose weight before her wedding, and then died in the arms of her fiance a few months later. Hers was the first wrongful-death suit filed amd would become the most important single suit the company would ever face.
Alicia Mundy provides a shocking and thoroughly riveting narrative. It is a stark look at the consequences of greed and a cautionary tale for the future.

Alicia Mundy: author's other books


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Table of Contents First this would not have been possible without the - photo 1
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First, this would not have been possible without the support of Brian Duffy, managing editor of U.S. News and World Report , which printed my article in February 1999 on which some of this book is based; and the support and encouragement of CBSs 60 Minutes Two and its producers Chris Riback and Wendy Krantz, who saw the importance of this story on several levels. And I must thank former Glamour magazine editor Mary Hickey, who called me the day after the drugs were withdrawn in 1997 and asked me to go to Boston to poke around the Mary Linnen case. See if theres any kind of story there, she said. Three reporters who cover the health industry were invaluable to me: Charlie Ornstein of the Dallas Morning News ; Donna Shaw of the Philadelphia Inquirer; and Ed Silverman of the Newark Star-Ledger. I also appreciated the input of Dave Wilman of the LA. Times; Cheryl Attkisson of CBS; Jean Jacques Chiquelin of Nouvel Observateur; Jon Marcus of Boston magazine; and Jeff Feeley of Bloomberg News.
Several editors from The New England Journal of Medicine gave me a lot of their time: Jerome Kassirer, Marcia Angell, and Gregory Curfman. Dr. Raymond Woosley and Dr. Carl Peck, both of Georgetown University Medical Center, are concerned with drug safety and with the integrity of scientific studies, and I thank them for their contributions. There were other medical editors, scientific researchers, cardiologists, pulmonologists, and epidemiologists, FDA doctors, and members of its advisory committees who did not wish to be mentioned by name. I thank them all. In addition, members of Congress and congressional staffers, and employees of the Department of Justice assisted my research and understanding of why things often dont happen as planned. I also need to thank the Center for Responsive Politics and the Center for Public Integrity.
Many victims and their families shared their stories with me and encouraged me to write this book. The Linnen family was very open with their thoughts andtime, despite the obvious pain it caused them recounting Marys last year. David Cote and others in the Box reminded me why you cant assume anything about jurors. Thanks also to Jonathan Harr, whose eloquent book, A Civil Action , helped inspire me.
Medical specialists who helped me were: Jack Crary and Pam Ruff, and the administration at MeritCare in Fargo, to whom I, and America, owe a huge debt; Dr. Gerald Simonneau; Dr. Lucien Abenhaim; Dr. Jules Hirsch; Dr. Lewis Rubin; Dr. Stuart Rich; Dr. Tom Wadden; and Dr. Robyn Barst. A special thanks to Dr. David Kessler. Drs. Richard and Judith Wurtman generously shared their experiences and knowledge with me. AHPs general counsel Lou Hoynes was kind and forthcoming about the Linnen case.
And last, but not least among the medical experts, I want to thank Dr. Leo Lutwak. No explanation needed.
Several other people supported me in several ways: Margaret Weaver the Retriever; Morton Ford; John Trevena; Larry Bachorik of the FDA; Mary Flannery of the Philadelphia Inquirer; and my Godfather Gar, who never gave up hope. A special debt is owed my sainted assistant, Jenna Land; the endlessly forgiving James English of Adweek and Bill Gloede of Mediaweek; Heather Jackson of St. Martins, who gave birth twice in one yearto this book and to her son; Heather Florence, St. Martins outside counsel, and my agent, part-time editor, and shrink, Howard Yoon, of the Gail Ross Literary Agency.
Theres a long list of lawyers who spent hours walking me through science, law, and the accidents that happen when the two intersect. But from the MDL, I need to thank Tom Smith, the doge of documents; the big-hearted Mike Fishbein and Arnold Levin; John Baker, David Suggs, Steve Sheller, Sol Weiss, Mike Koren, Dan Sigelman, Jerry Alexander, Ed Blizzard, Arthur Sherman, Marc Bern, Steve Rotman, Mike Schmidt, Denise Nearis, and Sharon Ericksen were very, very helpful. The inimitable Tom Pirtle, his assistant Chuck, and David Jacoby were very generous with their perceptions and experience. Mike Williams is in a category by himself. John Restaino was an angel of mercy. Michelle Parfitt, Liz Dudley, and Chris Tisi are barely mentioned, but their contributions weave through several chapters. Jim Gotz and David Ryan were kind beyond words. Kip Petroff and Redonda Gregg were always available, even in the middle of crises.
The book, of course, would not have been possible without the cooperation and Catholic guilt of Alex MacDonald and Maureen Strafford, who, along with Emma and Nora, were accessible at odd hours and in strange places. Although, as I wrote, Alex is possessed of an enormous ego, he never asked me to delete mention of incidentswhere he blew up, screwed up, or seemed foolish. The book represents what I witnessed and interpreted, not Alex or any of the other parties involved. And finally, a special thank-you is due to Robert Kisselburgh. Paul Newman never sounded so good.


We got our nastygram from [the MDL]. They are subpoenaing Dr. Lutwak and any and all records relating to the search for these documents .
My inclination is to tell [the MDL] what they can do with their subpoenas.
E-mail from Brett Golden, Office of General Counsel, FDA, October 19, 1999

A few weeks after the Mary Linnen case ended, on a cold night in February, as the wind whipped bitterly against his glass living-room wall, Leo Lutwak settled onto his sofa, swirling his Scotch, and stubbing a succession of half-smoked cigarettes into an overflowing ashtray. His son David set the VCR to record as The CBS Evening News began. Within a minute, Leo looked up to see himself on the screen, uttering the words FDA-gate.
Hed agreed to appear on television as a last resort, trying one final time to tell the world what was going wrong at the FDA. This time the disaster du jour was the diabetes drug Rezulin. But Leo was telling the CBS reporter that Rezulin was just the latest problem to surface, that it was part of the same health crisis as Redux and Pondimin, and they were linked. All the drugs he had warned his superiors about, such as Rezulin, Propulsid, and more, were being linked to peoples deaths, and the agencywas stalling. The FDA was repeating all the mistakes theyd made with the diet drugs, falling for the same ploys by the drug companies, folding like wet cardboard. They were tied too closely to the pharmaceutical companies, he warned.
Leo knew it wouldnt make much of a differencethe FDAs top officials would ignore him, knowing no one in Congress was going to take on the drug companies in an election year.
Well, a futile gesture is better than none at all, he sighed, sipping from a glass instead of plastic in honor of the CBS show.
For months, hed been trying to tell people what hed found out about the Fen-Phen scandal and the terrifying future it signaled. But he was tired of playing Cassandra. Hed been shut downnot by the pharmaceuticals but by his own agency. The FDA didnt need an insider telling everyone that the FDA had crawled into bed with the pharmaceuticals.
Looking back, Leo had thought that somehow his e-mails, his memos, would shake something loose at the top of the agency. Hed been foolish to think theyd listen to an old man on his way out. Alex MacDonald had called him a voice crying in the wilderness. He wanted to tell Alex, You have no idea how lonely the wilderness is.

There had been one brief period when he thought hed be heard at last, when he thought hed finally have his chance to set the record straight on Fen-Phen and about the FDA. Hed written his masterpiecea draft report showing exactly what the FDA had really been told about valve disease by the companies, when theyd received the information, and what the companies had told them about the Rat Study.
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