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- Veröffentlicht auf Amazon.com
Format: Gebundene Ausgabe
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 <speed>." 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, <My God, they've re-created Aminorex!>." (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.