by John M. Curtis
(310) 204-8700

Copyright June 6, 2000
All Rights Reserved.

lowing more smoke than Phillip Morris, the FDA finally banned Warner-Lambert’s 'miracle' drug Rezulin from the market on March 21, 2000. "We are now confident that patients have safe alternatives," said Dr. Janet Woodcock, the prestigious director of the FDA’s drug evaluation unit, finally pulling the plug on the deadly drug nearly two and half years after the FDA first received reports that the drug caused liver failure. "Safer alternatives?" Some statement from the very same person who just a few months earlier claimed, "In many patients it has proven to be very effective," conspicuously omitting the keyword safe. As undeniable evidence and loud objections mounted within the FDA, Dr. Woodcock dug in her heels, "People who felt that the drug was too risky really shouldn’t have prescribed it," quite a message from someone responsible for assuring public health and safety.

       Posting warning labels recommending liver function monitoring didn’t go far enough. For some inexplicable reason, Dr. Woodcock and her vaunted evaluation committee put on the blinders when faced with the avalanche of bad news about Rezulin. Warner-Lambert’s vested interest is obvious to almost everyone. But figuring out why the FDA fought tooth-and-nail to keep Rezulin on the market is truly mind-blowing. Medicine always prefers to err in the direction of caution. With the FDA’s new 'fast-track' system of drug approval, did they go too far too fast? Some people say yes. Others, like Dr. Alastair J.J. Wood of Vanderbilt University, felt posting warning labels was a useless charade. FDA approval—regardless of the time frame—assures safety and effectiveness. Right? Blaming physicians for prescribing Rezulin is like attacking short order cooks for serving bacon and eggs. Most people play the odds and know the risks if they’re given good information.

       "The drug’s risks outweigh its benefits," said British authorities back on December 1, 1997, banning the sale or distribution of Rezulin. Yes, back in 1997! With over 83 known deaths and endless complications to date, why the delayed response by the FDA? After Warner-Lambert’s efforts to reinstate Rezulin failed in 1998, the British Medicine Control Agency reasserted, "We do not have any recent data regarding additional benefits of Rezulin . . . nothing that isn’t already there with other drugs." On the heels of the British ban, the new head of FDA, Dr. Jan E. Henney, commissioned her top researcher on adverse drug reactions, Dr. David J. Graham, to conduct an urgent review. Graham’s ominous findings presented in March of 1999 were alarming, supporting the British conclusion that Rezulin was a public health risk: its adverse side-effects far outweighed any expected benefits.

       Over Dr. Graham’s warnings and objections, the FDA review committee, headed by Dr. Woodcock, voted 11-1 to keep Rezulin on the market. His superiors admonished him for 'over-reaching' and muzzled him from publicly divulging the contents of his report. Dr. Graham’s findings were certainly a bitter pill for Warner-Lambert—but surely no surprise to informed sources within the FDA. With Britain’s Medical Control Agency already banning Rezulin in December 1997, only physicians and their hapless patients were kept in the dark. Once a drug is FDA approved, manufacturers go into overdrive getting the drug on the market. With all the marketing hype about Rezulin, sales topped two billion dollars during its first year. Though pharmaceutical companies spend millions getting drugs approved, it’s no guarantee. Many people are still scratching their heads wondering how a toxic, even lethal, drug got through the door?

       Blaming this 'glitch' on 'fast-track' approval is a convenient smoke screen, especially when you consider that all approvals are based on properly controlled and completed scientific research. Whether it takes more time or less, the research is supposed to be clear and convincing. Getting to the bottom of how 'glitches' like this take place is no luxury matter. When the Los Angeles Times revealed that publicly traded pharmaceutical companies routinely pay scientists hundreds of thousands of dollars to conduct research on new drugs awaiting FDA approval, eyebrows were raised. When prestigious medical journals ignore their own ethical standards and publish research sponsored by pharmaceutical companies with vested interests in getting their drugs approved, the credibility of the whole system is called into question. Research scientists at major universities, funded by publicly traded companies, risk losing objectivity to satisfy their funding sources.

       Experienced scientists know that 'statistics don’t lie but liars figure,' attesting to the widespread phenomenon that researchers are under unacceptable pressure to produce favorable results. Drug safety shouldn’t be compromised by publicly traded predators seeking to gain fast-track drug approval by unduly influencing preliminary outcome research. Scientific research—as stated in journal's ethical guidelines—must be free from political leverage and, of course, money. How can researchers, whose grants and salaries depend on funding from pharmaceutical companies, produce objective research when their livelihoods are tied to their funding? Even universities risk losing grants and endowments if drug companies aren’t pleased with the results. Carrying this a step further, can major publications afford to lose massive advertising dollars by printing stories harmful to their sponsors? Questions like these go to the very heart how a free press disseminates true and factual information in the public interest.

       When egos and power-struggles eclipse rational judgment within the FDA, it’s time to take a searching inventory. Public health and safety simply can’t take a backseat to objectively evaluating the benefits and risks of medications. Arm twisting, political pressure and, yes, ego problems have no place in federal agencies mandated to cure diseases and save lives. Incalculable numbers of people die senselessly at the hands of well-intentioned physicians prescribing FDA approved medications whose risks and dangerous side effects weren’t properly considered. Blaming doctors who follow normal medical procedures and prescribe FDA approved medications that kill or maim their patients doesn’t pass the test of common sense. Federal agencies giving the green light must also have the integrity to admit they’ve made mistakes and show the humility to correct them.

About the Author

John M. Curtis is editor of OnlineColumnist.com and columnist for The Los Angeles Daily Journal. He’s director of a Los Angeles think tank specializing in human behavior, health care, political research and media consultation. He’s the author of Dodging The Bullet and Operation Charisma.

©1999-2000 Discobolos Consulting Services, Inc.
(310) 204-8300
All Rights Reserved.