More Holes Are Shown in the Safety Net for Drugs

In a logically designed drug safety system, data from new studies would automatically be pooled so that as more and more patients take a drug, researchers can see potential harms across all the data at one time, rather than looking at individual research studies in isolation. Alas, that is not our world.

A new proposal would change that, but it would take an act of Congress to do so.

As described in the Archives of Internal Medicine, a group of researchers analyzed all the studies published on Merck’s anti-arthritis drug Vioxx to see when the risk of heart attack could have first been identified. The drug was first put on the market in 1999 and was taken off the market in September 2004 when Merck said it first realized there were many heart attacks in patients taking it.

The researchers led by Joseph Ross, M.D., now say that their analysis, pooling data from 30 separate clinical trials, shows there was statistically significant increase in heart attacks in Vioxx patients as early as June 2001, three years before the drug was removed from pharmacy shelves. The studies after 2001 only strengthened the statistical association, they say.

If we had a system in place that automatically pooled all safety data on drugs as new studies are published, many safety risks could be identified much sooner.

But the head of drug safety at the Food and Drug Administration, Dr. Janet Woodcock, said Congress would have to authorize a change in the existing monitoring system to make for these automatic updates. Currently, she told the New York Times, the FDA does such combined-study reviews but only when a particular drug catches the eye of FDA safety officers.

Consumers are well advised to hold off on taking new drugs until they have been on the market for seven years. This is the advice I give in my book, The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.

Seven years is enough time for safety experts to see whether the new drug has enough benefits that outweigh its harms. In theory, the approval by the FDA to let a drug be sold should provide that green light, but before a drug is approved, only a few thousand patients typically are studied, while many hundreds of thousands will take a drug in the years after approval.

The new study by Dr. Ross and colleagues is yet another example of how far we have to travel before consumers can be assured that a brand new drug is right for them.

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