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The Denver Post November Al Lewis Column

November 30, 2004

Nov. 30–What you hear before taking prescription drugs versus what you learn afterward may make you feel like a lab rat.

Before: Bayer’s Baycol lowers cholesterol. After: But it also may cause muscle and kidney damage. Before: Vioxx stops arthritis pain. After: It may cause strokes and heart attacks.

Before: Antidepressants will curb your kid’s emotional problems. After: They also may promote overwhelming suicidal urges. But, hey, at least the kid won’t be depressed anymore.

This is what happens when pharmaceutical giants focus more on profits than drug safety and the Food and Drug Administration gets too cozy with an industry it’s supposed to regulate.

Baycol got recalled in August 2001, but now there are fresh allegations that some Bayer AG officials knew about the drug’s dangerous side effects before launching it in 1998.

On Sept. 30, Merck & Co. stunned investors and consumers when it removed Vioxx from the market. Merck also is under investigation for possibly withholding information.

Earlier this month, David Graham, an FDA researcher turned whistle-blower, told a congressional panel that Vioxx had caused more than 139,000 heart attacks and strokes, nearly 55,000 of which were deadly. Merck has disputed these numbers, calling them Graham’s speculation.

In October, the FDA ordered labels on all antidepressants warning that the drugs “increase the risk of suicidal thinking and behavior” in children.

It’s likely we’ll hear about more the perils of popular prescription drugs in the near future. Graham — who helped get the dangerous weight-loss drug Fen-Phen off the market years ago — told the congressional panel about five drugs that he suspects may prove dangerous.

New drugs bring new perils. That’s the history of medicine. But the biggest problem today is how adverse effects of new drugs are monitored after they hit the market. Essentially, the system relies upon pharmaceutical manufacturers to track the effects of their own drugs.

The nation’s drug-safety monitoring system is fraught with so many conflicts that the Journal of the American Medical Association called for a complete overhaul of the system in an editorial last week.

JAMA proposed a new, independent drug-safety board. In response, the FDA noted that the Institute of Medicine, part of the National Academy of Sciences, is already studying the system.

JAMA argues that the FDA is too heavily financed and influenced by the drug industry. It said the FDA received $825 million in fees from drugmakers from 1993 to 2003. JAMA also said pharmaceutical companies spent nearly $5 million lobbying the FDA last year. It noted that people on FDA review panels sometimes have stakes in the companies whose drugs they are reviewing.

These conflicts are the product of a society that can’t decide how much risk it would like to take with new treatments. In the late 1980s, the FDA was under fire for taking too long to approve new drugs. This led to the 1992 Prescription Drug Act, which bolstered the FDA’s budget by charging fees to drugmakers.

For better or worse, the money from fees has hastened the approval process. Median approval times fell from 27 months in 1993 to 14 months in 2001. But drug recalls following FDA approval rose from 1.56 percent to 5.35 percent during that time, JAMA reported.

Even with these higher recall rates, most drugs still prove safe, and their hastened approval may even save lives. If you end up taking a drug with undisclosed side effects, that may be of little comfort.

When Frayde Leventhal, 83, fell last year, her doctor sent her in for a brain scan. “I thought I was getting Alzheimer’s,” said the resident of Palm Springs, Fla. But the brain scan showed she’d suffered a minor stroke.

Her doctor called and told her to stop taking Vioxx. She says she hasn’t been the same since her stroke: “I sure don’t play golf anymore.”

Merck will soon be getting a call from her son, Jim Leventhal, 56, one of Colorado’s top malpractice attorneys.

Al Lewis’ column appears Sundays, Tuesdays and Fridays. Reach him at 303-820-1967 or alewis@denverpost.com.

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BAY, MRK,




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