BizJournals Portfolio

Out of Sight

Overseas clinical drug trials are becoming the norm, creating a need for tough new global standards and oversight.

Congress Blew It Congress Blew It

Business groups say Congress has overreached with unrealistic health care bills. Read More

VaxGen Gets No Boost From AIDS Study VaxGen Gets No Boost From AIDS Study

VaxGen Inc. has generated hope for an AIDS vaccine but remains troubled. Read More

Dead on Arrival Dead on Arrival

Skeptics doubt health co-ops will lower prices or boost the number of insured. Read More
1 of 2 NEXT

How dangerous are pharmaceutical clinical trials that are conducted overseas?

The question was in the news repeatedly this year as Pfizer, the world’s biggest drugmaker, tussled with the Nigerian state of Kano over a 1996 clinical trial of its Trovan antibiotic. The testing took place during a meningitis epidemic, and Pfizer was held responsible for 11 deaths and dozens of injuries.

For months, Pfizer executives were on the defensive, especially after a federal appeals panel ruled that dozens of Nigerians could sue the drugmaker in a U.S. court. So this past July, a $79 million settlement was reached, with most of the fund to be used to establish health care initiatives there and to settle claims. Bad publicity aside, the payout was a far cry from the $2 billion that Kano officials had sought.

But the damage was done—the long-running dispute highlighted sobering questions about whether the pharmaceutical industry follows international law and properly offers informed consent to patients, which has become a flash point in a growing debate over the ethics of running clinical trials in other countries.

“This whole topic is a big concern,” says Vera Sharav, an industry critic who heads the nonprofit Alliance for Human Research Protection. “There may be exploitation of enrolled patients. You may also get drugs that are based on data that was obtained improperly and then approved here by the FDA. And that’s because there’s insufficient FDA oversight of these trials.”

The issue is gaining attention because more trials are run in foreign countries. Nearly one-third—or 157 out of 509—clinical trials registered on a federally run website are being conducted overseas, according to an article earlier this year in the New England Journal of Medicine. Meanwhile, more than half of all trial sites—13,521 out of 24,206—are outside the U.S., with many located in Eastern Europe and Russia, where oversight standards are evolving.

blog comments powered by Disqus
 
Great Global Business Adventure

To win in the global race, don't get distracted by competitive noise and focus on your clients.

David Duncan sees signs of sales rebounding at his candlemaking firm Paddywax.

If you’re in cleantech, you’re a global business, even if you’re local.

spotlight on

Football Fever

Gridiron Green

Who is more valuable, a star quarterback who makes $14 million a year or a player on the bench who pulls in a fraction that amount? In the NFL, a big paycheck doesn't necessarily mean big performance. Read More