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

by Alicia Mundy

Mary Linnen, 29, was determined to lose 25 pounds before her wedding. In May 1996, her doctor prescribed a combination of drugs known as Fen-Phen. When Linnen complained of dizziness and shortness of breath 23 days after starting the medications, her doctor told her to stop the drugs--but didn't examine her or order tests. Linnen got better for a time, then the shortness of breath and exhaustion returned worse than ever. Her legs and stomach swelled. She collapsed at work. Six months after taking Fen-Phen, Linnen was admitted to the emergency room with primary pulmonary hypertension: the capillaries that sent oxygen to her lungs had thickened and were closing, suffocating her. Her survival expectation after heart surgery was less than four years. Hooked up to a tube in her chest to prevent heart failure, she died three months later.

Dispensing with the Truth: The Battle over Fen-Phen tells the story of the legal battle against the pharmaceutical companies after Fen-Phen's users started dying--some, like Linnen, of primary pulmonary hypertension; others of heart valve damage. Investigative reporter Alicia Mundy weaves a dramatic tale from the development of the drugs to FDA approval to the final litigation. How much did the pharmaceutical companies know about the risks long before most of the deaths? Plenty, according to the evidence Mundy reveals. Although at times the book seems overfilled with details that slow down the drama, if you want the complete, behind-the-scenes story of one of the most famous "profits over protection" cases, this book tells all. --Joan Price

Genres: Nonfiction, History, Medical

421 pages, Kindle Edition

First published May 11, 2001

Reviews

[Sheri]

I didn't read the whole book, but it was interesting because one of my instructors was involved in this lawsuit as a paralegal and came out of their settlement with a 6 figure bonus!!!! Wow!!

[Dennis Littrell · Rating 4 out of 5]

Important story, well-told

This is a good read, especially in the beginning, but if you want to go beyond the courtroom drama and the legal aspects of the case, you have to read carefully. (Taking notes wouldn't hurt.) This is a complex story, and one has to admire Alicia Mundy's skill in managing it while spinning out an engaging narrative. She succeeds by concentrating on one case, that of 29-year-old Mary Linnen, an Orchard Park, New York woman, who developed primary pulmonary hypertension (PPH) after using the Fen-Phen drug combination for a mere 23 days. There is no cure for PPH, and the treatments amount to something like sustained torture. Tragically, less than a year after diagnosis, Mary Linnen was dead.

Within her story, Mundy focuses on two main characters. One is the engaging and colorful Alex MacDonald, the lead attorney representing Mary Linnen's estate, who along with many others sued American Home Products, the parent company of Wyeth-Ayerst, the distributors of Pondimin and Redux (one half of the deadly Fen-Phen diet cocktail), for wrongful death; and the other is Leo Lutwak, a well-meaning but ineffectual administrator at the Food and Drug Administration. But I think the real story here is the corporate mentality inside the drug companies that led to the tragedy, and the incompetence at the FDA that allowed it. Although I think Mundy concentrates too much on the lawyers in her narrative (she indicates in the "Acknowledgments" that she was inspired by Jonathan Harr's lawyer-centered A Civil Action), she is still able to give a complete story, but it takes some real effort on the part of the reader to get it all. I had to take notes and flip back through the pages with the aid of the Index to keep Pondimin and its "sister" drug Redux separate from Phentermine, and to realize that it is the combination of Pondimin and Phentermine or the combination of Redux and Phentermine that is the deadly Fen-Phen combo. When one looks deeper it becomes apparent that Pondimin is the brand name for the drug fenfluramine and Redux for dexfenfluramine, the "Fen" in "Fen-Phen."

It's an important part of the story to realize that doctors prescribed Phentermine in combination with Pondimin because Pondimin alone led to unwanted drowsiness while Phentermine "was," as Mundy phrases it on page 39, "after all, a form of ." The logic here, although not mentioned, is similar to that of the hugely successful Sudafed combination of the antihistamine Chlorpheniramine Maleate, which leads to drowsiness, and the nasal decongestant Pseudoephedrine Hydrochloride, which counteracts that effect by speeding up your system.

Still, it's not clear why so people so eagerly gobbled up the Fen-Phen combo. Mundy indicates that part of the reason was a massive advertising and PR campaign spun out by the drug companies--she calls it "Obesity, Inc."--a campaign that made the never-proven claim that over 300,000 Americans, mostly women, die each year from the "disease" of obesity. The drug companies positioned themselves as wanting to save those lives. However, Mundy cites a study on page 155 showing that the long-term expected weight loss from using Fen-Phen was only about three percent above that of a placebo.

To me the most unsettling part of this story is the stupidity practiced by the FDA and by Wyeth in not realizing that Pondimin or Redux in combination with Phentermine was in its effects very similar to Aminorex, an appetite suppressant that caused a major epidemic of primary pulmonary hypertension, killing hundreds of people in Europe during the mid-1960s. (p. 38) Mundy quotes John Restaino, "a young doctor turned lawyer," as saying (p. 198), himself quoting an unidentified Swedish scientist, "When I saw the combination of Pondimin and Phentermine, Fen-Phen, I said, ." (Incidentally, the lack of attribution for some of the text--there are no footnotes--is a disappointment.)

This bit of ignorance, perhaps willful, by Wyeth and the FDA was followed by a frenzy of greed when the drug companies realized the potential profits. This in turn was followed by attempts at obfuscation and cover-up, denial and feigned ignorance, when the deadly side effects became public knowledge. Ironically, it wasn't PPH that finally led to the withdrawal of the drugs, but another, also deadly side effect, that of heart valvular disease, uncovered by two Fargo, North Dakota residents, med tech Pam Ruff and cardiologist Jack Crary. To my mind, their story is the most important part of the book. Their unselfish and courageous work led to the withdrawal of the drugs and saved the lives of untold numbers of people.

Bottom line: this is an engaging read about a preventable tragedy and the triumph of litigation against a big corporation to be ranked with A Civil Action (the book, not the so-so movie) and the Erin Brockovich story.

--Dennis Littrell, author of “The World Is Not as We Think It Is”

[Megan · Rating 2 out of 5]

A look behind the legal battle over Fen-Phen and the horrific deaths caused by the diet drug, this book captures corruption in the FDA, a lack of ethics in pharmaceuticals, and the various legal teams representing the victims of the drug. I discovered this older publication thanks to the podcast Maintenance Phase.

The story itself is compelling; the author centers the story around a particular woman and case that has you eager for justice. The "good guy" lawyers are fun to read about as well. There are other, more frustrating parts of the book that made it a drag in several places. This included circular discussions of the same issues where it was difficult to discern what made it new and worth talking about again, a wide range of characters combined with confusing use of pronouns, and some groan-worthy analogies (and I quote, "Alex was becoming a hot dog, and he was on a roll" - seriously?!).

While there were moments I enjoyed, I wound up glad in the end that it was over, despite an unsatisfying conclusion. Stick with the podcast; the host read it so you don't have to.

[Julian Hunt · Rating 3 out of 5]

Alicia Mundy’s writing style is a bit overwrought. She seems very impressed by money and power: I could do without the descriptions of attorney Alex MacDonald’s home, second home on the beach, the parties at each, his loving devotion to Alan Dershowitz (does NOT age well…), etc. Trial attorneys are not the big deal she seems to think they are. I stuck with the book to the end to get a look at the problems with FDA and cozy relationship with drug companies, but it was quite a slog.

[Siobhan · Rating 5 out of 5]

4.5 rounded up. Proves that a book can be gripping and depressing at the same time. Read at least for the realization that there's nothing really preventing this from happening again.

[Michael · Rating 4 out of 5]

This is the story of how American Home Products, now Wyeth, marketed two diet drugs that caused heart valve damage and a fatal lung disease called primary pulmonary hypertension. Mundy does a comprehensive reporting job and writes it up in a clear, compelling style.