Opinion by Nicholas Regush, ABCNews.com

It's high time the federal government offered doctors some economic incentive to prescribe drugs more appropriately to patients.

Say, coupons for free economy mini-vacations to Tahiti for those doctors whose patients suffer no more than two somewhat serious drug side-effects in one fiscal year, or the latest model T-bird for those who have demonstrated near-clean patient serious drug side-effect records for a decade.

This would, of course, require a novel patient drug monitoring system that would enable rewards to be properly distributed.

Better FDA Labeling For Harried Doctors

This forward-looking approach is actually partly inspired by an obviously frustrated Food and Drug Administration, which apparently believes doctors should share some of the blame for drug side-effect injuries and deaths because many do not read warning labels.

To correct the shameless disregard for labels, the FDA proposed new labeling regulations late in December that would very quickly reveal a drug’s biggest danger in highlighted text at the top of the packaging. The busy doctor, it is expected, would be able to process the crucial informationin about 30 seconds.

That’s optimism for you, since few doctors read the labels, instead learning about new drugs from pharmaceutical salesman unlikely to emphasize the risk. One federal regulator suggested to me a few years ago that many doctors would only take great care in reading labels and warnings if a free hamburger coupon was attached. He wasn’t kidding.

FDA Passing Buck to Doctors

But critics of the FDA are likely to take a cynical view of how the agency may be trying to pass the buck to doctors. It’s worth recalling that the FDA has had to yank about a dozen drugs from the market since 1997, mainly because scores of deaths and numerous life-threatening side-effects were associated with these products.

Public Citizen’s Health Research Group, for example, has regularly condemned the agency for its speedy, short-cut safety approvals of powerful prescription drugs. The pressure for the FDA to cut corners has largely come from drug industry-influenced members of Congress who have deluded themselves into believing that a speed-up will help benefit the overall health of Americans.

Drug Approval Short Cuts Lead to Hospitalizations

Well, an estimated two million drug-related hospitalizations a year and tens of thousands of deaths say otherwise.

Furthermore, most of the new drugs on the market are mimics of drugs that already exist, save for a small molecular change in the recipe. Only a handful of drugs in any year can truly be considered "breakthrough."

Congress, fed by drug-industry re-election money, has been conning the public for many years.

So what do we make of this mess? A failed FDA, jerked around by politicians and a medical profession in need of a swift kick. And the situation is likely to get much worse because the FDA is fast-tracking more drugs that are often very tricky to prescribe.

Consider the Rezulin debacle. The FDA quickly approved this highly controversial diabetes drug that required detailed and regular monitoring of a patient’s liver. The FDA and Parke Davis/Warner Lambert, of Morris, N.J. pulled Rezulin off the market after 63 deaths due to liver problems were associated with its use.

Whose fault was it? Certainly the FDA’s because of the irresponsible quickness of approval and the long delay in yanking Rezulin Certainly Parke-Davis’ because of the company’s reluctance to stop sales. And certainly the medical profession’s because of the vast over-prescribing of this drug.

In any case, without massive revamping of FDA priorities and practices, there’s not much hope in stopping the maiming and the killing going on. And I don’t expect the drug industry to behave any better either. And forget about Congress getting smart on prescription drugs.

A New System of Side Effects Reporting

This is why my hope, small as it is, rests with the doctors. But these folks badly need to be goosed in a positive manner. No point shouting at them or editorializing about them. It’s like water off a duck’s back.

Let’s make the drug prescribing system look more like an airline’s frequent flyer club. Set up a system of rewards that will bring smiles and sharp lines of attention to the faces of those prescribing drugs and perhaps even the courage to be free of drug-industry poking and promising.

The new system can work like this: Each patient prescribed a drug would be legally bound to keep a log of perceived side-effects and to turn that log over to their doctors, say, six times a year, or whenever a side-effect appears to be serious. The doctors would be legally obligated to turn that log over to a new federal agency within three days.

That new agency would set up -- for the first time -- a true surveillance system, one quick to react to patterns of claimed drug side-effects. It also would dole out rewards to doctors based on log-performance. This should have a strong, positive effect on medical practice.

If this initiative screws up, we can then blame the patients for not keeping proper logs.

ABC News Second Opinion January 3, 2001

Nicholas Regush produces medical features for ABCNEWS. In his weekly column, published Thursdays, he looks at medical trouble spots, heralds innovative achievements and analyzes health trends that may greatly influence our lives. His latest book is The Virus Within.

CLICK HERE to view "The Virus Within" by Nicholas Regush at Amazon.com.

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