"Dispensing With the Truth" has Hollywood movie written all over it. Alicia Mundy's book about the diet drug fen-phen includes every necessary element: otherwise healthy woman dies horrible, painful death after taking diet pills for a mere 23 days. Devastated family hires intrepid lawyer who soon discovers that the pharmaceutical company peddling the pills knew that the drugs were dangerous. There are incriminating memos, documents that suddenly go "missing" and shady dealings with the federal government. Think "Erin Brockovich" or "A Civil Action" -- a courtroom drama pitting presumably powerless human beings against greedy corporations.
The two pharmaceutical companies behind fen-phen pulled the popular diet pill combination from the market in 1997 after it was belatedly revealed that the concoction caused severe lung and heart disease. By that time, between 6 million and 7 million people had already purchased the "fat pills" that promised to help them lose weight fast; years later, hundreds of thousands of those customers are at risk for heart valve damage and a lethal lung disease called primary pulmonary hypertension (PPH). But Mundy's most chilling observation is that the fen-phen disaster was eminently preventable: before fen-phen became a craze, evidence already existed that the drugs were dangerous.
Who was responsible for putting such a dangerous drug on the market? "Dispensing With the Truth" draws a circle of culpability; Mundy unearths a long list of people who made appallingly bad decisions. The pharmaceutical companies concealed or ignored the potential danger of the drug in order to preserve their booming profits; an impotent FDA buckled under pressure from lobbyists and pharmaceutical companies and refused to listen to its own early warning system; the media blindly trumpeted the fen-phen phenomenon and then boosted biased studies that were funded by the pharmaceutical companies. As a result, hundreds of women died, and many thousands more are still suffering.
"Dispensing With the Truth" serves as a blueprint for the decision-making process of this country's pharmaceutical industry: the story of fen-phen is hardly an anomaly. Over half a dozen popular drugs have been recalled in the last few years alone. So before you pop that next pill, it's best to know what the people who were selling it to you were really thinking. "Dispensing With the Truth" is likely to make you reconsider what prescriptions you put in your body.
Fen-phen is not one drug, but a combination of two drugs: Pondimin, sold by Wyeth-Ayerst (a division of American Home Products, makers of Robitussin and Advil), and Phentermine, from Fisons. Both Pondimin (also known as fenfluramine) and Phentermine were moribund diet-drug standbys which failed to achieve popularity in the '80s and early '90s -- primarily because of severe side effects, such as drowsiness.
The fen-phen ascent to popularity began in 1992, when Dr. Michael Weintraub discovered that the combination of the two drugs cancelled out the side effects. An Allure article on the new diet-drug combination in 1995 jump-started the craze; by 1997, between 6 and 7 million women in America had taken fen-phen (as well as Redux, a sister drug similar to Pondimin). Not only did obese women with significant weight problems use fen-phen, but so did women who obtained their prescriptions from "pill mills" and diet centers in an attempt to take off a mere 10 or 15 pounds. Wyeth-Ayerst didn't rush to stop the craze: Instead, it counted its cash and estimated that it would reap $900 million in sales of Redux alone by 1998.
But even as fen-phen rose in popularity, the medical community began to grumble about the drug's dangers. In France, identical drugs were pulled off the market in 1995, after ten of the world's foremost experts studied the pills and produced a report arguing that Pondimin and Redux users were ten times more likely to contract a lethal lung disease called primary pulmonary hypertension (PPH). A year later, an updated version of the report revised that number to show that the risk actually increased 2,300 times. Still, the drug stayed on the market.
Meanwhile, doctors in Fargo, North Dakota, noticed that young, otherwise healthy women were entering local hospitals with severe heart valve problems; it appeared that fen-phen could be the culprit. With the help of the prestigious Mayo Clinic, the group documented 13 cases of heart valve failure in Fargo alone and sent the ensuing study off to Wyeth-Ayerst in March 1997. The group's prediction was dire: According to their calculations, roughly 30 percent of the diet pills' users would develop some degree of heart-valve disease after being on the drug for only three months. Fen-phen wasn't just going to help you lose weight; it was also threatening to permanently damage your heart.
Even with warnings from the nation's premier medical clinic, it took over six months for the drugs to be pulled from the market -- six months of time in which thousands more women started up fen-phen programs. Not surprisingly, after the drug was recalled Wyeth-Ayerst was inundated with tens of thousands of lawsuits, and one mammoth federal lawsuit.
Mundy uses one of these lawsuits -- the case of Mary Linnen -- to tell the fen-phen story. Mary, who wanted to lose 25 pounds in order to fit into her wedding dress, took fen-phen for just 23 days before she came down with the symptoms of primary pulmonary hypertension. Within months, Mary was forced to undergo an operation that inserted a tube into her heart, so that she could inject a drug called Flolan directly into her heart several times a day. Mary went on Flolan in late 1996 but died less than three months later. Linnen's family sued for wrongful death -- the first fen-phen lawsuit filed against Wyeth-Ayerst -- and eventually settled for a whopping $15.5 million. It was just the first of a wave of lawsuits that Wyeth-Ayerst lost; in fact, the pharmaceutical company has not won a fen-phen related lawsuit yet.
As for that federal lawsuit: 300,000 people joined the mass settlement by the end of 2000 -- some who simply wanted to be reimbursed for the expensive echocardiogram tests necessary to diagnose valve disease, and some who actually needed open-heart surgery, lifelong medication or Flolan tubes. Wyeth-Ayerst has put aside $12.25 billion to pay off the settlement; "more than its total net income for the last decade," writes Mundy.
The thousands of FDA and Wyeth-Ayerst documents that the lawyers unearthed during their research speak volumes about the mentality of both the pharmaceutical companies and the government agency that is supposed to monitor them. For example, an e-mail from Dick Wurtman, the inventor of Redux, says: "The coordinated attack on REDUX during the past few weeks is part of a conspiracy -- led by FAT WOMEN... to make EVERYONE fat, by taking away the only effective medication to keep people from becoming so..." Or a memo from Wyeth's vice president for women's health, admitting that their drugs didn't even work, and that on average a 200-pound person would lose only 6 pounds more on Redux than with a placebo: "The efficacy of Redux is not impressive, and is insufficient for the needs of the patients the doctors would like to prescribe it for."
Then there are the millions that Wyeth-Ayerst used to support doctors who conducted studies which conveniently concluded that fen-phen was safe after all, such as one study by Georgetown doctor Neil Weissman (bankrolled by Wyeth-Ayerst for $18 million) which landed on the front page of USA Today just after the drug was recalled. New England Journal of Medicine editors later revealed that his report was severely flawed, but not before it received copious media coverage.
Completing the circle of culpability is the government. Not only did the FDA repeatedly cave in to the demands of pharmaceutical company lawyers and lobbyists -- approving Redux, despite the fact that several staff scientists had serious reservations about the drug's safety, and then rescinding its demand that Wyeth-Ayerst use a "black box" label flagging the drug's lethal side effects -- but FDA administrators also sat on the Mayo Clinic's studies for months. European officials had red-flagged these drugs years earlier; why didn't our government do the same?
Mundy is hardly a neutral reporter: Her book is rife with moral indignation and incredulous disbelief. But the facts back up her anger: She produces study after study, e-mail after e-mail, and legal document after legal document to prove that the pharmaceutical pipeline in the United States has major, life-threatening defects. It is a dense and circuitous but fascinating read.
An argument can be made that any medicine that is supposed to help some people will also hurt some others. Certainly, Wyeth-Ayerst and the doctors who prescribed fen-phen wanted to help the obese -- and morbid obesity is a serious illness that does kill many people every year -- but the damage that ensued was far greater than the good that the drugs did. Your average fen-phen user lost only 3 percent more weight than she would have had she just popped a sugar pill, and she risked permanent heart and lung failure in return. It's a high price to pay to look good in a bikini.
This story has been corrected.