By Gilbert Ross, M.D.
Posted: Thursday, August 13, 2009

EDITORIAL
Publication Date: August 13, 2009

This piece appeared on August 13, 2009 in the San Francisco Examiner and August 14, 2009 in the Washington Examiner:

Sen. David Vitter (R-LA), under the agreeable eyes of his Democrat colleagues in the Senate, tacked an amendment easing importation of foreign pharmaceuticals onto an essential funding bill for Homeland Security. Here's hoping the amendment won't survive the upcoming House-Senate conference on the bill.

While many think of them as a cheap alternative to domestic drug purchases, the so-called "Canadian" drugs allowed under the Vitter Amendment can come from almost anywhere on the globe. It's an easy path for substandard and toxic drugs to enter our supply.

How ironic that this is being done under the umbrella of homeland security. Forget terrorism and contagion. Few things could undermine the safety of the homeland more than allowing drugs of uncertain provenance to mingle with homegrown, safe, effective, FDA-approved pharmaceuticals.

Even more threatening, though, is the potential damage that allowing importation would do to our pharmaceutical industry's ability to develop the next generation of lifesaving, innovative drugs. Importing cheaper foreign drugs en masse would by definition mean importing foreign price controls.

This sounds like a boon to customers in the short term, but where government-imposed drug price controls are in place -- including Europe, Japan, and Canada -- drug research and development withers. The profit motive is removed from the drug business, hurting customers in the long run.

Almost no innovative new drugs have been developed over the past fifteen years by European pharmaceutical companies, as compared to American blockbusters.

During that time, laws imposing price controls on drugs have been standard in Europe, Canada, and Japan. The pharmaceutical research moved to the U.S.

Why? Innovative new drugs have only a short time to recoup on the huge expense involved in discovering, testing, and marketing them. Only a tiny minority of new chemical entities make the cut, and getting them to market routinely consumes over a decade at a cost of about $1 billion.

The World Trade Organization treaty that permits price controls in much of the world (on the condition the drugs aren't imported to the U.S.) also allows poor countries to violate drug patents and produce knockoffs if those countries deem it necessary for public health. This can mean simply deciding that the companies aren't sending them enough cheap drugs already (perhaps in part because the companies fear many of the drugs will simply be sold back to the U.S. at artificially low prices). Examples of this occurred relatively recently with AIDS drugs in Brazil and Thailand.

Imposing price controls here -- which is what importation, in effect, does -- will lead to stagnation in our own drug research and development process. Our children and grandchildren will have to accept 2009-quality drugs far into the future.

Let's hope that this anti-business, anti-consumer amendment is stricken from the legislation, as similar amendments have been in the past. That way we will will avoid a future in which fewer lifesaving drugs are discovered and made available to us and our progeny.


Dr. Gilbert Ross is medical director of the American Council on Science and Health.