80% of Approved US Drug Trials Done Outside US – What?!?

July 1st, 2010. By Hunter West

 

“As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained.”

– Daniel R. Levinson

A recent report by the inspector general of the Department of Health and Human Services reveals just how much pharmaceutical drug testing is going on in the shadow of foreign shores… 

Eighty percent, according to Daniel R. Levinson. That’s 80 percent for trials of all drugs approved for sale in the US by the Food and Drug Administration (FDA) in 2008. 

Wow. 

What’s more, 78 percent of all subjects who participated in clinical trials were enrolled in foreign sites for drugs given the nod that year. 

For some time now, there has been concern about the quality of drugs manufactured offshore. China comes to mind. Look at the heparin debacle of a few years ago. While there is massive incentive for drug companies to manufacture on foreign soil for the cost savings (and the better bottom line that goes along with it), the downside is that often you don’t know what you’re getting. 

And now, the revelation that most drug testing is going on somewhere else. 

That’s troubling, because in both cases—manufacturing and testing—the FDA lacks both the financial and staff resources to properly monitor things. 

Check out some of the numbers contained in Levinson’s report, released towards the end of June and summarized in The New York Times. The FDA inspected fewer foreign clinical trial sites, than domestic sites. While that may not be a surprise, the percentage of sites the FDA gets around to inspecting at all, IS. 

What percentage of DOMESTIC sites would you think the FDA would get around to seeing? Seventy-five percent? Fifty percent? You would expect foreign sites to be audited at a much lower rate due to time for travel et al, but a fairly high inspection rate for domestic trial sites, right here on home soil, would be assumed. 

Guess again. 

In 2008, according to Levinson’s report, the FDA got around to checking up on just 1.9 percent of domestic clinical trial sites. The foreign camp is even worse, at 0.7 percent. 

And while we’re on the subject of the FDA, Levinson’s investigators were unable to inspect detailed clinical trial data for 29 of the 129 approved drug applications for 2008. For eight of those applications, the FDA failed to locate any part of the application in its storehouse of information. 

The point is—if the FDA is having this much trouble keeping track of what’s going on here at home, one can imagine things are going to get worse before they get better with the increasing number of drug trials conducted offshore. 

It is important to note that foreign clinical trials can, and do yield invaluable information with regard to various ethnic groups. It is also important to point out that most foreign clinical trial sites—and trial participants—were located in Western Europe. It is generally believed that ethical controls over research in Western Europe is equally robust as that found here. 

But—and there is always a ‘but’—according to Levinson’s report, Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. 

And remember those numbers? 80 percent of all drugs approved for sale in 2008 had trials in foreign lands, with 78 percent of all trial participants—in ALL trials—were enrolled at foreign sites. 

Looking at it another way, only 20 percent of trials were conducted domestically, with just 22 percent of all drug trial participants located in the good old red, white and blue. 

Other voices: 

“I think this report just confirms the potential problems with foreign trials,” said Dr. Adil E. Shamoo, editor in chief of Accountability in Research, a journal about research ethics. “There is less liability, patient recruitment is far easier, the concept of informed consent is not well established, and it’s cheaper.” 

And the report “highlights a very frightening and appalling situation,” said Representative Rosa DeLauro, (D-Connecticut). “By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”

Tags: Clinical Trials, Drug Approvals, FDA

This was posted on Thursday, July 1st, 2010 at 9:47 am and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.