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New York Post.

The Right Road to Safe Drugs
December 28, 2004

By Robert Goldberg

RECENT revelations about the risk of heart failure from long term-use of painkillers like Vioxx, Celebrex and Aleve have shaken public confidence in pharmaceutical companies and the Food and Drug Administration.

It should.

The FDA uses decades-old technology to evaluate whether a drug is safe, technology that can't help Mr. or Mrs. Smith tell if a drug is safe for them as opposed to safe "on average."

We can do better. The FDA can make drugs safer by embracing cutting-edge scientific tools that can reassure each American that his or her medicines are safe and effective.

Drug companies and the FDA conduct experiments clinical trials that show the drugs work and that the benefits of the medicines outweigh the risks. That system set up when modern molecular biology was in its infancy is good at detecting whether a drug has widespread side effects. It is not so good at discovering whether a small group of people would suffer increased risk of illness or death.

Nevertheless, critics of the current system seem to think that the way to fix a flawed system is to make it larger. They propose bigger clinical trials with more tests proposals that would add tens of millions of dollars and many years to the drug development process.

Yet those proposals won't make drugs any safer, because problems will still crop up years after drugs are on the market their system just cannot test enough people to identify all possible side effects before a drug is approved. But the added cost and delay will deny people with serious illness access to new drugs, denying them the chance of living fuller and longer lives.

The solution isn't to simply expand the FDA's one-size fits all approach to drug testing, but to replace it. Using modern science, companies and the FDA can develop a "personalized medicine" path to drug development. This personalized approach identifies which groups of patients might be more likely to get a side effect from a medicine. It also tailors drugs to treat patients who are at risk for a certain disease or condition based on their genetic makeup.

This isn't science fiction: Genomas, a personalized medicine company based in Hartford, Conn., has identified genetic links showing which people are at high risk for side effects of many drugs and which people won't respond at all. Many cancer drugs work in this targeted fashion.

More personalized measurement of a drug's effect will lead to faster and smaller studies to prove a drug is safe and effective. That means drugs will be less expensive to develop and more profitable to produce. It also will mean fewer blockbuster drugs mass-marketed to the public as a whole, reducing the possibility that people will be exposed to a drug that is generally safe but which causes side effects for those with their genetic makeups.

Drug companies must move quickly to embrace such reforms if they want to address safety concerns and restore public confidence. in the health care system. And President Bush should appoint a new FDA commissioner committed to those goals.

The president's previous choice for FDA commissioner, Mark McClellan, launched a Critical Path initiative that made the personalized medicine approach the new gold standard of drug development for both industry and the FDA alike. A new commissioner committed to Critical Path would help keep the fear mongers at bay.

Smarter science, not more government regulation, will give us the safer and better medicines we all want.

Robert Goldberg, Ph.D., is director of the Center for Medical Progress at the Manhattan Institute.

©2004 New York Post

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