Doctors who have relied on Food and Drug Administration approval and recommendations in prescribing new drugs for their patients got a major wake-up call Sunday. A front page story in The Los Angeles Times reported the FDA approved Warner-Lambert’s diabetes drug Rezulin over warnings, by its own medical officers, of liver toxicity.
We are not talking here about common side effects noted in TV advertising of popular prescription drugs: nausea, vomiting, diarrhea — unpleasant, but not life threatening. Just the body’s way of saying, “Stop! You’re poisoning me!” We are talking about liver failure. When your liver fails you can get seriously dead. Rezulin is not a life-saving drug. All it does is lower blood-sugar levels in diabetes patients, and there are already more than half a dozen drugs on the market that do that without the risks.
So why would Warner-Lambert downplay the incidence of liver damage to patients in its clinical trials? Well, $2.1 billion in sales sounds like a pretty good incentive. That’s what the drug earned during the three years before it was withdrawn last spring. And only after it was suspected in 391 deaths, including dozens involving liver damage.
The bigger question is why the FDA would disregard the evidence, even removing its own doctor from the review process.
Years ago we used to get mad at the FDA for taking so long to approve drugs that had been in use all over Europe. The agency seemed to spend a lot of its resources picking on the little guys. Like a small company that manufactured the best yucca supplement for arthritic animals. Dogs and horses with painful, stiff joints were taking yucca and running and jumping pain free. And nobody was dying. Still, the agency nitpicked about labeling claims and wound up putting the company out of business and even threatened to jail the owner. Come on. Talk about a misuse of power.
About 10 years ago, comfrey tea was yanked from health food store shelves after two cases of liver failure were reported in people who drank several quarts a day. Even though those cases were linked to a shipment of the herb that was reportedly contaminated by pesticides, comfrey disappeared, probably forever.
Now, it was my experience that comfrey was an exceptionally effective herb, useful in healing ulcers. I used to grow my own comfrey, dry the leaves and brew them into a strong tea, which I strained and chilled. There was nothing better for healing deep wounds and scrapes. And I’ve had gophers eat away the entire root system of a comfrey plant (they’re huge) without experiencing liver failure, though I wouldn’t have minded if the marauding rodents had expired.
Anyway, the whole focus of the FDA changed radically during the past decade. Once known for the glacial pace of its approval process, the agency yielded to pressure from drug companies to speed up approval for experimental AIDS drugs. Safety is, I suppose, less of a concern for someone suffering from a terminal disease. Congress also leaned on the FDA to work with drug manufacturers to make new medicines available. Even President Clinton reportedly urged the FDA to treat the drug industry as “partners not adversaries.”
The role reversal had an almost immediate effect. In 1988, for example, only 4 percent of new drugs worldwide were approved first by the FDA. By 1998, that number shot up to 66 percent. During the same period, approval rates for industry applications jumped from about 60 percent to 80 percent. Could they all be that safe and effective?
Dumping its safety-first approach, the FDA became the last to withdraw seven hastily approved drugs after European authorities banned them. These were not needed to save lives, but they produced life-threatening reactions like liver and heart damage: Lotronex for irritable bowel syndrome, the diet pill Redux, antibiotic Raxar, blood pressure medication Posicor, pain killer Duract, the heartburn remedy Propulsid, and Rezulin. Do people really need to risk death from liver and heart failure to lose weight or relieve heartburn?
Documents, internal memos and e-mails between the FDA and Warner-Lambert, obtained by Times reporter David Willman, and depositions in several lawsuits against the drug company, tell a sordid tale, one that suggests political meddling in the approval process, abuse of power by the agency, obfuscation and falsifying clinical trials by the drug companies and maybe collusion.
And who pays? Taxpayers, doctors and patients. Some pay with their lives.