Profits Ahead Of Patients?

Defense attorneys Ronald Kaye, left, and Marilyn Bednarski speak to reporters after a jury convicted Chi Mak, a Chinese-born engineer, of conspiring to export U.S. defense technologies to China and being an unregistered foreign agent, outside the Federal Courthouse in Santa Ana, Calif., Thursday, May 10, 2007. Mak worked on submarine technology for an Orange County defense contractor.

Long before the diabetes drug Rezulin was pulled from the U.S. market, it was in serious trouble — there was mounting evidence it was causing deadly liver failure.

Eleven other countries had rejected it. But drug maker Warner Lambert kept selling Rezulin in the U.S. with the FDA's approval, reports CBS News Correspondent Sharyl Attkisson.

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

"They made over a billion dollars on the drug."

She represents hundreds of alleged Rezulin victims, including the family of Monica George, a woman who died three years ago. They 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," said Littlepage.

The Complete Investigation
  • FDA: Guardian Or Rubber Stamp?
  • Rezulin Suits Illegal In Michigan
  • FDA Defends Actions On Rezulin
  • FDA Whistleblower Resigns
  • FDA Opts For Safer Diabetes Drugs
  • Another FDA Whistleblower Speaks
  • FDA Whistleblower Faces Probe
  • Did Manufacturer See Rezulin Danger?
  • Rezulin: A Chronology
  • Drug Maker Wants Rezulin Review
  • Some Drugs Approved Too Soon
  • When The Cure Proves Fatal
  • Rushing Drugs To Market
  • There were enough adverse events in Rezuli's first months on the market, that Warner Lambert finally added that advisory for doctors to monitor patient's liver function.

    And the company 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 reported 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."

    A Warner Lambert executive was asked about that in a deposition for a lawsuit.

    Wright Witcher, Vice President of Marketing for Warner Lambert was asked in a deposition on April 9, 2001, "Is that appropriate for your sales force to be out in January 1999 telling doctors that this drug is safer than the FDA suggests?" To which he responded, "For us to say that a drug is safer than the FDA suggests is a conflict of the purposes of this system."

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

    "You need to remember, doctors don't necessarily remember what reps talk... 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," said Witcher.

    Dr. Donald Marks is an expert witness for Rezulin victims. He's 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, which they don't release the info to the FDA in a way that would alert the FDA to the magnitude of the problem."

    Warner Lambert, now part of Pfizer, wouldn't answer our questions but in a statement said 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 Rezulin was the best drug available at the time, and 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."

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

    ©MMI, CBS Worldwide Inc. All Rights Reserved