Dispensing With The Truth

[Guest guest]

Wednesday | June 6, 2001

Fen-phen: Thin at all costs 06/06/2001 By ALINE McKENZIE / The Dallas Morning News In a new book, journalist Mundy follows a trail of corporate cover-ups, bureaucratic weakness and greed that led to more than 100 deaths from the diet-drug combo fen-phen.

If you took fen-phen or Redux Anyone who took the drugs for more than two months is automatically part of the class-action settlement and may be entitled to a free heart screening and other benefits. For more information, call 1-800-386-2070 (toll free) or visit www.dietdrugsettlement.com.

But whatever the manufacturers and government did wrong in marketing and regulating the drug combination, the fiasco would not have been possible without the public's massive demand for a "magic pill" for thinness. "What are you going to learn from this? 'Some drugs are dangerous, but it's not the one I'm taking right now?'" Ms. Mundy says. "I've interviewed women who say that if the drugs were still available, they'd take them despite the risk. ... How much can you complain about the drug companies if people won't learn?"

At the height of its popularity in the late '90s, fen-phen – a combination of two drugs called fenfluramine and phentermine – was taken by at least 6 million Americans, along with a related drug called Redux.

The combination turned out to cause thickening of the heart valves and a fatal, suffocating lung condition. Wyeth-Ayerst, the maker of fenfluramine and Redux, pulled the drugs from the market in 1997.

Wyeth-Ayerst's parent company, American Home Products, has agreed to pay out $11.2 billion to settle the thousands of lawsuits.

Ms. Mundy's book, Dispensing With the Truth, focuses on two cases: those of a Massachusetts woman who died from the lung condition, and a Grand Saline, Texas, woman who developed heart-valve problems.

The Dallas lawyers who handled the Texas case get a large chunk of the book to themselves. Kip Petroff and Kisselburgh refused to join East Coast attorneys in a group federal case, instead pursuing a separate lawsuit and obtaining documents and depositions on their own.

"I think Texas kept everyone honest," Ms. Mundy says.

What shocked her was how many levels of greed and weak oversight she found, with the documents and e-mail to back it up.

"Every time I'd stand back and say, 'That's the story, there's nothing else to find,' it would just spiral," she says.

The first chapter starts with a quote from a Wyeth-Ayerst administrator's e-mail, asking, "Can I look forward to my waning years signing checks for fat people who are a little afraid of some silly lung problem?"

"That just knocked me out," Ms. Mundy says. "...You so rarely see things on paper, the way I saw here."

Much of the book deals with the company's battle with the Food and Drug Administration, which wanted to put a "black box" warning label on fenfluramine and Redux. The warning – literally, a black frame highlighting the dangers of the drugs – would have cost the company an estimated $800 million in sales.

"I'm beginning to wonder what other companies have similar paper trails of the FDA wanting more warnings," Ms. Mundy says.

In retrospect, she says, the speed with which drugs are now approved was part of the problem. The faster approval process began during the AIDS crisis, when experimental lifesaving drugs needed to get out to patients. But the same rules shouldn't apply to "lifestyle" drugs for weight loss, allergies, hair loss and so on, she says.

"It's going to take Congress to slow them [drug companies] back down."

There are still some prescription weight-loss drugs on the market, including phentermine, Meridia and Xenical, but none has reached the popularity of fen-phen, and Ms. Mundy says doctors have learned to be more cautious.

"Doctors ... are doing what they're supposed to do, only prescribing it to people who are terribly overweight and monitoring them, which was not happening with fen-phen."

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

Purposes for which the Corporation (NSIF) is organized are to perform the charitable activities within the meaning of Internal Revenue Code Section 501©(3) and Texas Tax Code Section 11.18 ©(1).Specifically, the Corporation is organized for the purposes of education and research of Silicone-related disease.

Attachment: vcard [not shown]