09/07/1998 at 01:00 AM EDT
Diane Ayres was just following doctor's orders when she gulped down a large yellow pill with her grapefruit juice that morning in October 1992. Within hours, though, the frightening symptoms began. "I felt a melting sensation behind my eyes. I had a tingling sensation in my arm," she says. "I thought, 'My God, I'm having a stroke.' "
Later that day emergency room doctors at Pennsylvania Hospital in Philadelphia determined that Ayres, now 42, was in fact having an adverse reaction to a single 300-mg tablet of the antibiotic Floxin, which had been prescribed for a minor infection. Instead of clearing up the problem, the drug had attacked her central nervous system, triggering a harrowing, difficult-to-diagnose manic-depressive condition that was heralded by symptoms such as severe insomnia and dramatic mood swings, and would rage on for the next three years. Confused and angry, her husband, journalist Stephen Fried, 40, wasted little time in contacting the U.S. Food and Drug Administration and Ortho, the drug's manufacturer, for information and guidance; he even scoured the Internet to try to find out why his brilliant, vivacious wife had become so dreadfully ill. It was the beginning of a five-year odyssey that would take Fried deep inside a $90 billion-a-year industry, earn him a National Magazine Award, set off new FDA investigations into antibiotic safety and culminate in his explosive book Bitter Pills: Inside the Hazardous World of Legal Drugs. Diane's crisis, Fried learned, was less unusual than he had ever imagined.
Adverse drug reactions to legally prescribed medicines are among the leading causes of death in the U.S., killing an average of more than 100,000 people a year, according to a recent study in the Journal of the American Medical Association. (Illicit drugs, by contrast, kill some 5,000 to 10,000 people a year.) While some medications with dangerous side effects, like fen-phen, a diet drug combination that has been linked to heart-valve problems, and Accutane, an acne remedy that can cause birth defects, have been widely publicized, the full dimensions of the problem are not generally recognized. And with more than 2.5 billion drug prescriptions dispensed to patients each year, it is probably impossible for pharmaceutical companies to eliminate all risks of side effects or dangerous combinations of drugs. Fried says it will take a more concerted effort from all involved—including doctors, patients, pharmacists, the drug industry and the FDA—to make a dent in the problem. "This is a country that believes in checks and balances," he says. "We can't expect the drug companies to police themselves."
Fried understands the benefits medicines can provide—another drug, after all, has enabled Diane to resume her own writing career—and he warns people not to stop taking their prescribed medication. "Putting the industry out of business," he says, "is not the answer."
Neither is placing the blame on doctors, who generally get little pharmacology training after medical school. "Doctors know that drugs are the one thing they know the least about," Fried says. And the FDA (which Fried calls "the best regulatory agency in the world") lacks the money, manpower or legal mandate, he says, to effectively monitor the nation's 14th-largest industry. While researching Bitter Pills, Fried learned that the government had been wrangling with the industry for more than a year over warning labels for Floxin and related antibiotics.
If there is one thing Fried and Ayres have learned, it is the need for patients to take a more active part in their own health care. Some experts advise people to fill all prescriptions at the same pharmacy, where potentially harmful interactions may be spotted by computer databases, and to tell their doctors about all their medications.
For Ayres the best cure was the devotion of a man she first met at a Valentine's Day party in 1986 and wed a year later. "It was love at first sight," says Fried, who hails from Harrisburg, some 200 miles from North East, Pa., where Diane grew up. "I always thought of Stephen as my rock," she says. "When I became sick that became more apparent."
Early on, Ayres decided not to sue Ortho. The couple's focus was on getting Diane better. Her persistence was rewarded: She recently sold her first novel and now works six to seven hours daily in an office on the third floor of their South Philadelphia row house. "We had a real tight, close relationship before this all happened," says Ayres. "And now it's just tighter and closer."
Bob Calandra in Philadelphia