Drug safety has its own side effects

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Article Published: Tuesday, November 30, 2004

Drug safety has its own side effects

http://www.denverpost.com/Stories/0,1413,36~33~2565945,00.html

 

By Al Lewis

Denver Post Business Columnist

 

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.