Undermining drug safety

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Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.

It seems inconceivable that you or I could find a way to take lifesaving drugs and turn them into lethal weapons. But most drugs and devices wind up causing side effects because of the human inability to follow directions. Indeed, safety problems with drug-coated heart stents boil down to this: Don't put them in patients with really blocked arteries who stop taking clot-busting medicine. The fact is, coated-stent use will be restricted, as it is with many drugs and devices, because we can't be trusted to do as we are told.

This picture of incompetence clashes with the one politicians and the Institute of Medicine peddle to the media of an FDA and drug industry rushing to approve and market medicines without regard to product safety. But a Centers for Disease Control report found that misuse and overuse of a handful of old medicines cause most dangerous side effects. Hundreds of thousands of emergency-room visits occur because of adverse drug events. The CDC notes that "Sixteen of the 18 drugs most commonly linked to adverse drug events in the study have been in clinical use for more than 20 years." The most common drug classes were insulin, painkillers containing opioids, anticlotting drugs (including aspirin), drugs containing the antibiotic amoxicillin and cold remedies.

Yet, the media and politicians pick on pills that are well known rather than risky. Ambien is a classic example. Ambien became famous (or infamous) when Rep. Patrick Kennedy claimed he crashed his car because it caused him to drive while sleeping. Thereafter, Ambien became the target of major articles in the New York Times and Washington Post for being linked to sleeping while shoplifting, midnight snacking, etc. In fact, as the folks at blogcritics.org point out: "In 2004, over 24 million prescriptions for Ambien were written. Let's say that each contained 30 pills. That's 740 million times people took this sinister drug in 2004. Timothy Morgenthaler, a Mayo Clinic researcher, reported five cases of sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can't link to Ambien. In fact, only 48 have been linked to this killer drug.

"It's well known that adverse incidents are under-reported, so let's assume a factor of 100... That's 4,800 incidents over, say, 8 years or 600 a year. No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008 percent or something like 1/80,000th of a percent."

Sen. Charles Grassley wants to withdraw an antibiotic called Ketek. His evidence? The drug -- used to treat sinus infections, bronchitis and treatment-resistant pneumonia -- was approved on the basis of the nearly a decade of clinical trials, the drug's five-year safety record in Europe and a 25,000-patient study in America that unfortunately involved one doctor who faked results for about 300 patients. (The doctor was sent to prison and the results discarded.) Some claim the approval ran roughshod over time-honored FDA standards and explains why there are 23 reports of liver injury associated with 10 million Ketek prescriptions since 2003.

In fact, the FDA can approve a drug with the results of one clinical trial and prior experience with a drug. Antibiotics with amoxicillin are more likely to cause liver problems than Ketek. Acetaminophen is the most common cause of liver failure in the United States. The FDA, more concerned about drug-resistant bacteria than are fact-resistant senators, is keeping Ketek on the market.

We have defined down drug safety. What used to be our responsibility is now blamed on a FDA-industry conspiracy. We blame shoplifting and car crashes on Ambien, not on reckless behavior. Suicide, a tragic mystery, is suddenly the result of Prozac-type anti-depressants. Heart attacks are now caused by Vioxx, not by hypertension and smoking. No wonder the current FDA reform bill requires restrictions on the use of every drug that make OSP limits look like child safety locks. We want our drugs -- and our tacos -- to be 100 percent safe. They can be, if we stop making medicines available altogether. I am afraid we are already there.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest.