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Did Rezulin Maker Deceive Doctors About Drug's Deadly Effects?

Long before the diabetes drug Rezulin was pulled from the market, there was mounting evidence it was causing deadly liver failure. CBS's Sharyl Attkisson has the story in an Eye on America investigation.

Eleven other countries had rejected Rezulin, but drug maker Warner Lambert kept selling it in the US--with the FDA's approval. They made over $1 billion on the drug.

Attorney Zoe Littlepage says pharmaceutical companies have huge financial incentives to keep dangerous drugs on the market.

She represents hundreds of alleged Rezulin victims, including the family of Monica George, who died 3 years ago. The families claim Warner Lambert knew about Rezulin's risks before and after it went on sale but failed to properly warn the public. The motivation, say the lawsuits, was financial.

Littlepage argues Warner Lambert must have recognized the potential danger early on, because it drafted a label advising doctors to monitor their patient's liver function. But the company deleted that instruction from the final labeling for Rezulin.

"What does that mean? Patients start taking this drug that the company knows is liver-toxic! And they're not being monitored, and patients start dying," Littlepage says.

There were enough adverse events in Rezulin's first months on the market that Warner Lambert finally added the advisory for doctors to monitor patient's liver function.

The company also officially told its sales force to get the message out to doctors. But the sales force did just the opposite--and Warner Lambert executives knew it, according to internal company surveys.

As deaths mounted over the next year and a half, doctors who were surveyed by the company said the actual message they were getting from Warner Lambert was that Rezulin was "safer than [the] FDA suggests" and the "media hype regarding liver test is overblown."

Wright Witcher, vice president of marketing for Warner Lambert, was asked to address this in a deposition for a lawsuit: "Is that appropriate for your sales force to be out in January 1999 telling doctors that this drug is safer than the FDA suggests?"

"For us to say that a drug is safer than the FDA suggests is a conflict of the purposes of this system," Witcher said.

Still, Witcher suggested that maybe his sales force didn't say that at all: It's only what doctors claimed they were told.

"What people report they remember is not necessarily the same as what was presented to them, and that's the vagary we have to deal with," Witcher said.

Dr. Donald Marks is an expert witness for Rezulin victims. He has worked inside the pharmaceutical industry and as a consultant for the FDA. He has seen other drug makers drag their feet to keep risky drugs on the market while raking in profits.

"Many times the pharmaceutical company will know months in advance of a problem, but they don't release the info to the FDA in a way that would alert the FDA to the magnitude of the proble," said Dr. Marks.

Warner Lambert--now part of Pfizer--wouldn't answer our questions. The company said in a statement that it never withheld safety data, didn't know about Rezulin's potential for liver damage until after it went on sale, and then acted promptly. The company has also argued that Rezulin was the best drug available at the time and that the benefits far outweighed the risk.

But Littlepage argues the company was measuring the cost of risks versus profits. "The goal isn't to keep the drug on the market forever. The goal is to keep it on the market today and tomorrow and next week," she says.

Warner Lambert sold $2 million worth of Rezulin each day the drug stayed on the market. When it was finally withdrawn last year for safety reasons, it was linked to 63 deaths from liver failure.
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