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Www.Wired.Com - : Photo: Associated PressThe history of medicine is rife with missteps. Even with today's standards in biochemical sciences and well-funded clinical trials, bad drugs can get into consumers' hands.
We smirk that the words mercury and curative were once lumped together. Or that heroin was part of a physician-sanctioned regimen. But who knows what problems our present ignorance will cause in the future.
In an effort to know the past in order to avoid repeating it, let's take a look at some drug recalls from recent history and the stories that led to the drugs' demise.
Left: Thalidomide
From the late '50s to the early '60s, a German manufacturer sold thalidomide under 40 different brand names in 50 countries. Designed to relieve morning sickness and let pregnant mothers rest, the popular drug soon turned into a nightmare.
Children all over Europe and Africa were born with catastrophic birth defects because of the drug. No one knows exactly how many cases were linked to thalidomide, but one estimate of birth defects put the number at more than 10,000 children.
The United States was spared, however, thanks to the Food and Drug Administration. Frances Oldham Kelsey received a request from a company to bring the drug to the United States, but she had reservations about its safety. Despite pressure from the company, and the fact that dozens of other countries had approved the drug, Kelsey persisted in asking for further studies. Her fears were soon confirmed when studies began linking the drug to birth defects. Kelsey was instrumental in shaping legislation regarding the FDA's oversight of pharmaceuticals. She received national recognition from John F. Kennedy for her role in averting the threat.
: Blockbuster Drugs Gone Bad: Redux
The cover story of a September 1996 issue of Time magazine asked, "The New Miracle Pill?" Doctors sure thought so, scribbling out 85,000 prescriptions a week and driving $300 million in sales that year.
Redux was part of the popular "fen-phen" diet plan, which stands for fenfluramine and phentermine. Taken alone, Redux (which was dexfenfluramine, a derivative of fenfluramine) produced drowsiness and mood swings. But when patients accompanied Redux with phentermine, they felt better, stayed on the pill and dropped the pounds. Trouble was, the combination also led to heart valve disease. A 1997 Mayo Clinic article reported 24 patients with abnormal heart valves. Other studies followed and, by September of that year, the FDA asked the company to pull the miracle from shelves. In all, the drug was linked to 100 deaths and cost American Home Products (now Wyeth) billions in settlements.
: Blockbuster Drugs Gone Bad: Vioxx
Vioxx was one of the most-successful product launches in history. Approved by the FDA in 1999, it was the most heavily marketed drug in the world by 2000. Doctors wrote 92.8 million prescriptions in the United States alone, and the medication's worldwide sales garnered Merck $2.5 billion a year.
A member of the COX-2 inhibitor family of drugs, along with Bextra and Celebrex, Vioxx offered potent pain relief for arthritis sufferers. But studies and lawsuits soon cast a pall over the drug's success, claiming it increased the risks of heart attack and stroke. Merck retired the drug in 2004. Subsequent reports by the FDA suggest the drug was responsible for more than 27,000 deaths.
: Photo: Kai Pfaffenbach/ReutersDoesn't Play Nice With Others: Seldane
In 1985, Seldane became the first non-drowsy antihistamine. But a few years later, this "breakthrough" drug was traced to cases of fatal heart-rhythm irregularities. It turned out that when combined with drugs and even some foods (like grapefruit juice), toxic levels of the drug could build up in the body.
The FDA launched a broad effort to warn physicians and patients of these unsafe combinations, but in 1997 Allegra hit the market, offering non-drowsiness without life-threatening side effects. Seldane was soon retired, but not before making its mark on drug safety. It led the FDA to require more rigorous testing on interactions -- get this -- before drugs go to market.
At left, Juergen Ruettgers, Germany's research and technology minister, visits the chemicals and drugs company Hoecht Marion Roussel -- makers of both Seldane and Allegra -- in Frankfurt in 1998. The minister is standing in the human insulin plant.
: Image: Computer IllustrationsDoesn't Play Nice With Others: Posicor (Mibefradil)
When the heart medication Posicor was approved in 1997, its label warned users of dangerous interactions with three other drugs. Posicor itself was harmless, but had the unenviable ability to greatly increase the blood levels of other drugs.
Unfortunately, the warning list didn't stay at three. By 1998, Posicor was known to be toxic in combination with 25 different drugs. Concern grew that doctors and patients wouldn't be able to keep up with the "don't take if you're using" directions. Since Posicor offered no real advantage over other drugs in its class, the FDA recommended it be voluntarily removed.
: Image: Courtesy CNNPassed Despite Resistance: Rezulin
The diabetes medication Rezulin stumbled out of the gate in January 1997 already under intense scrutiny. From there, things just got more sinister.
Dr. John Gueriguian, the medical officer appointed to assess the drug, voiced his disapproval due to high liver toxicity. Walter-Lambert, the drug's maker, didn't want to see its "potential blockbuster" get busted. They complained, and the FDA stripped Gueriguian of his post and discarded his report.
Soon after hitting the market, though, Rezulin was linked to sudden liver failures. Other FDA scientists sounded the alarm. After downplaying risks of the drug for three years, the FDA was forced to admit it had made a mistake. In March of 2000, Rezulin was pulled, a leading suspect in 391 deaths.
: Photo: Mike Derer/APPassed Despite Resistance: Duract
Duract was another case of the FDA ignoring its own advice. Medical officers warned repeatedly of the drug's liver toxicity, but the FDA assured them that a warning label could offset those risks.
However, patients are notorious for not following directions. Too many people were staying on the painkiller far longer than the 10 recommended days. Stronger warnings were issued, but by the time the Wyeth-Ayerst company released its voluntary reports, Duract was implicated in 68 patient deaths. The company agreed to shelve the drug less than a year after its release.
: Photo: CorbisI Wish That I Knew Then What I Know Now:
Baycol (Lipobay in Germany)
Some drugs show little toxicity in the small sample sizes of FDA studies, but when tens of thousands of patients start popping pills, different trends can emerge. This was the case with Baycol. Along with other cholesterol-lowering "statins," (like Lipitor), Baycol had been tied to rare cases of a breakdown of muscle cells, called rhabdomyolysis, which led to kidney failure. However, the FDA felt Baycol's lifesaving effect of unclogging arteries outweighed that risk and approved it in 1997.
With a small slice of market share, few problems were reported. As doctors got the drug to more patients, it became clear that Baycol was more dangerous than initially believed. Announcing that it had been linked to 100 deaths, Bayer voluntarily retired the drug in 2001.
: I Wish That I Knew Then What I Know Now:
Zelnorm
You might remember the weird commercials with women of different ages, sizes and races standing around with writing scrawled on their bare bellies. Zelnorm used a gigantic direct-to-consumer advertising campaign. The drug worked well for women afflicted with irritable bowel syndrome and, a few years later, was even approved for men.
The drug's company, Novartis, had a great find on its hands, until it released the results of a study March 2007 that caused the FDA to sit up in alarm. Citing the report, which found increased risk of heart attacks and stroke in Zelnorm users, the FDA asked Novartis to pull the plug on the drug -- and those weird commercials.
: Photo: CorbisP.R. Nightmares: Tylenol
While a recall usually spells the end for a drug, Tylenol's 1982 recall of its popular pain med may have saved both lives and the product. In late September 1982, seven people in the Chicago area died after taking Tylenol capsules that had been tainted with potassium cyanide: Someone was going into drugstores and tampering with pills.
Johnson & Johnson, the parent company of Tylenol's distributor, ceased production and implemented a nationwide recall of all Tylenol products. Though consumer confidence was shaken and authorities never found the killer, analysts say Tylenol's quick response reassured customers and saved the brand. Two months later, it was back on shelves in "triple-sealed" packaging to alleviate consumer fears.
The photo compares a sample of extra-strength Tylenol (left) with a cyanide-laced capsule (right), in the Cook County Medical Examiners' office in Chicago on Oct. 2, 1982. The cyanide makes the contents grayish and lumpy instead of smooth and powdery white.
: Image: matmo1/YouTubeP.R. Nightmares: Encaprin
To be fair, Encaprin may have been doomed from the start. Tylenol was a giant in the painkiller market, and the recent release of both Advil and Nuprin made Proctor & Gamble's pill a tough sell. But Encaprin's demise was sealed in 1986 when an anonymous caller told company headquarters that he had tampered with bottles at Chicago- and Detroit-area Walgreens and Kroger stores.
Both stores pulled the product off their shelves, and P&G issued a recall. Even though the scare was eventually revealed as a hoax, Encaprin never recovered and was quietly retired. On the plus side, the scare helped lead to the current requirements for tamper-proof packaging.
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