Hidden In Plain Sight

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After shoulder surgery, Darlene Rutherford's doctor prescribed a new painkiller called Duract. It worked wonders. What she didn't know was that while it was relieving her pain, it was destroying her liver. After three months, she fell into a coma and needed an emergency liver transplant, reports CBS News Correspondent Sharyl Attkisson.

"She was actually down to days to live, before they found her a liver," said Darlene's husband, Lloyd.

As it was, the only liver warning on Duract's label was mildly worded and buried so deep in tiny print, her doctor didn't think it would be a problem.

"As I understand it, when the drug came out it was supposed to have a black box label on it; it didn't," said Lloyd.

"We didn't find that out until after I had taken it," recalled Darlene.

A "black box" is a special warning — the strongest possible. The FDA's medical officer had wanted one on Duract's label to alert doctors to the risk of liver damage. But a black box can damage sales, and Duract's maker, Wyeth-Ayerst, argued against it.

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Negotiations got so heated, the FDA Medical Officer assigned to the drug accused the drug-maker of crafting a label to avoid blame, so that "the physician will be sued" instead of Wyeth-Ayerst in the event of fatal liver damage.

But the company convinced FDA officials to reject their Medical Officer's advice: there would be no black box.

Such nasty negotiations aren't unusual when millions of dollars in sales are at stake, according to Dr. Donald Marks, who works in the pharmaceutical industry and consults for the FDA.

"If the pharmaceutical company believes that black box will be the kiss of death for a product then they will argue with the FDA. They'll apply the pressure of members of Congress; they'll use the pressure of leaders of industry, popular figures — to not have a black box warning," said Marks.

And it's not just the dreaded black box — every single word on a drug's label or in ads is open to bargaining and debate.

Ads for the arthritis mediine Celebrex have been cited three times for overstating benefits, but the FDA has little power to police companies' claims. The agency has issued hundreds of warnings about exaggerated claims or side effects drowned in a sea of confusion.

"Sometimes pharmaceutical companies will list every adverse event that occurs in order to make the major adverse event seem of less importance in the overall picture," says Marks.

Dr. David Flockhart, who is head of Georgetown University's Medical Center Division of Clinical Pharmacology, studies labeling issues and is convinced that confusing and misleading labels are putting patients in jeopardy every day.

"At the moment what we're doing is dangerous because there's a surfeit of information. And the people who need to know the information and look after people and the patients to care for their own health can't get it. They can't see the forest for the trees," warns Flockhart.

New Drug Labels
Read the FDA's proposal on a new user-friendly format for prescription drug labeling (in .pdf format).
That's why the FDA is now working on a proposal for new user-friendly labels that would include a prominent section highlighting what doctors really need to know. The pharmaceutical industry agrees there's a problem, and is deciding whether to support the FDA's plan.

In the case of Duract, Wyeth-Ayerst finally agreed to add that black box it fought so hard against. But only after the drug had been used by thousands and was linked to serious liver damage.

"I'm just glad that she's here alive and doing well.," said Lloyd Rutherford.

But even a black box couldn't save Duract. In less than one year, it was pulled from the market — blamed in four deaths and eight liver transplants, including Darlene Rutherford's.

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