Clinical trials conducted abroad spike, public health officials say

An overwhelming majority of new drugs approved for sale in the United States in 2008 had clinical trials in other countries, according to a new public health watchdog report. And 10 of those new drugs were entirely tested outside the U.S., according to the report. The inspector general's office with the U.S. Department of Health and Human Services released the report earlier this week, and already public health advocates are sounding the alarm.

While most of the international trials were conducted in Western Europe, whose medical ethics and drug trial protocols general mirror those of the United States, that's not true of all of them. Some of the tests were conducted in parts of the globe where such protocols and patient protections lag behind the United States and Western Europe. Some public health advocates point to the fact that Central and South America had the highest number of clinical trial participants per site and accounted for 26 percent of all patients enrolled in foreign trial sites, according to an analysis of the report by the New York Times. It's much harder for public health agencies in the United States, where the developing medicines will eventually be sold, to ensure the safety of trial participants when the trials are abroad, advocates note.

The public health report "highlights a very frightening and appalling situation," Rep. Rosa DeLauro (D--Conn.), told the Times. "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the (drug) industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health."

Often, drug makers can gain information about the efficacy and potential side effects of their developing medicines by conducting clinical trials abroad. But tests conducted outside of the United States are more difficult for public health agencies here to police. It can be more expensive and cumbersome to audit clinical trial sites abroad, especially when the trial may be splintered among several countries, the Times noted. The inspector general report noted that often the Food and Drug Administration, tasked with approving new drugs for use and sale in the United States, often doesn't know that a clinical trial was conducted outside the United States until the drug companies applies for approval, which can be years after the trial phase has ended. But the FDA isn't doing itself any favors, either; its data collection system is flawed. The inspector general's public health report noted that in too many cases, the FDA was unable to provide full information about the clinical trials it was supposed to have received as part of a drug maker's application for approval.

It's not a big surprise that the FDA would have incomplete data. The agency has weathered accusations of inefficiencies and ineffectiveness for years. Recently the Obama administration has sought to beef up the agency, but so far at least that effort appears not to have taken root. What do you think?

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