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The Vaccine Balance
The New York Times, 1-29-05

GlaxoSmithKline is marketing a vaccine first in a very unlikely place – Mexico. Europe and the U.S. are usually the markets of choice for manufacturers of new drugs and vaccines, because of our lavish spending on health care.

Where the profits are, the medicine follows. Still, this vaccine, which immunizes children against rotavirus infection, is desperately needed in the developing world, where the virus kills hundreds of thousands of children every year due to dehydration from vomiting and diarrhea. Thus, Glaxo’s decision to market the vaccine in Mexico represents something of a sea change in industry practice.

“Glaxo plans to extend [Rotarix, the rotavirus vaccine] to other Latin American countries and Asia by the end of the year. It has applied for approval in Europe and will eventually do so in the United States….Glaxo is speeding the vaccine directly to where it is most needed. It’s a long overdue step that makes perfect sense.”

Why is this “long overdue step” finally happening? To paraphrase the film Field of Dreams: if you build a market, supply will come. Thanks to enormous funding from the Gates Foundation, “the Global Alliance for Vaccines and Immunization…is giving the poorest countries a pot of money to buy vaccines and assuring manufacturers of a market.”

However, we shouldn’t forget that the FDA and the European Medicines Agency are still the gold standard for drug regulation. An earlier rotavirus vaccine, made by Wyeth, was pulled from the American market because of the possibility of a rare side effect that might kill 1 in 10,000 children. In a rich country, where few children die from diseases like this, this may be a sensible decision. However, in poor countries the risk to reward ratio is completely different—while waiting for Glaxo’s vaccine, tens of thousands more children died because Wyeth’s was pulled from the market.

The FDA and EMEA should step forward with an approval process that gets treatments for diseases in poor nations out as quickly as possibly, while identifying rare potential safety problems that might be fixed or ruled out through additional research. We should treat vaccines for diseases in developing nations the same way we treat cancer drugs for American patients—if no other treatments are available and the choice is between death and a rare side effect, it is always better to risk the side effect.

Project FDA.
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