Jewish World Review July 25, 2003 / 25 Tamuz, 5763

Drs. Michael A. Glueck & Robert J. Cihak

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Consumer Reports

Drug reimportation: Bill translates to goodnight, patients | Sometimes the Powers That Be and the Powers That Wannabe try to bribe you directly. More often, and far more insidiously, they buy you indirectly, by offering to "save you money." The Gutknecht "Drug Reimportation Bill", tentatively scheduled for a vote in the U.S. House of Representatives at the end of the week, seeks to do both.

This item would make it legal for Americans to purchase drugs from 26 foreign countries (including American drugs previously exported), and would suspend the requirement that the Food and Drug Administration certify these pharmaceuticals as safe and effective.

So, what's wrong with that? Your Medicine Men hold no great affection for the FDA, with its bureaucracy-driven drug-approval processes and excessive caution. We do cherish open markets and competition. And there's already a thriving (if illegal) U.S.-Canadian trade in prescription drugs.

Just spend some time at any major border crossing, watching the American seniors head north to get their subsidized drugs ... while Canadians of all ages flock south for treatments unavailable under their system. Not to mention the Internet commerce.

By some estimates, Americans spend well over half a billion dollars annually on such drugs. Those who travel to Canada to purchase drugs need not be alarmed, as this practice remains legal with or without the Gutknecht Bill.

So, what's the dilemma?

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There are at least three dilemmas.

The first is patient SAFETY. Free and easy importation from 26 countries could lead to a flood of counterfeit drugs; to an influx of expired drugs that have been repackaged; and to drugs manufactured, stored and transported under unknown conditions. We could be importing poisons maybe even terrorism.

Further, many advanced American drugs aren't even allowed into other countries. Reimporting what's available somewhere else because it appears to save money may often mean foregoing, or even not knowing about, the most effective treatments.

Which brings us to the second dilemma: MONEY. Contrary to popular belief, Canadians on average pay about as much as we do for drugs. This is especially true for generic drugs whose patents have expired. Since it all depends on what an individual needs, savings may be illusory.

But money here has another aspect. Pharmaceutical research and development costs. The average drug takes about $800 million from inception to FDA approval to market. Profits from sales have to amortize this investment. They also have to pay for all the work that ends up in failure; for drugs for rare diseases that will never turn a profit; and for all the drugs that the firms sell (here and abroad) at discounts for various reasons.

Massive reimportation could well have a sadly deleterious effect on future R&D especially if coupled with massive violation of patent and other intellectual property rights. Let's not forget that without R&D we might not have combated AIDS or the latest resistant organism de jour.

The third dilemma involves a philosophical MINDSET perhaps best depicted as "Who needs cows? We get our milk from cartons." The Gutknecht bill is just one more part of a massive state assault upon American medicine.

Indeed, the only reason why it's coming to a vote at all is that Missouri Congresswoman Jo Ann Emerson, a Republican, swapped her vote for the overall Medicare bill for a guarantee that the House would vote on reimportation. The Medicare Bill, be it noted, passed the House 216-215.

In return, Emerson demanded a full House vote on a bill by Minnesota Republican Gil Gutknecht that would make it legal for Americans to take "advantage" of socialistic countries' government-imposed price controls by reimporting our own prescription drugs.

Politicians buying citizens, yes. But such wholesale purchase would not be possible were Americans to realize that health care, like the rest of civilization, does not happen automatically, and is never free. And it's being destroyed by those who think that it can be.

This legislation is an irresponsible political trick. Congressional leaders of both parties know its dangers. Congress needs to say goodnight to the Gutknecht bill.

Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical- legal issues. Robert J. Cihak, M.D., is past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here.


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