Healthy Skepticism Library item: 1579

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Schmit J.
Costs, regulations move more drug tests outside USA
USA TODAY 2005 May 16;

Full text:

The pharmaceutical industry is doing more human testing of drugs outside the USA in an effort to get drugs to market faster, lower costs and test drugs where they’re likely to be sold.

The industry spent more than $39 billion on research and development last year, with human drug testing accounting for the biggest cost, says the Pharmaceutical Research and Manufacturers of America. More than 21% of that was spent outside the USA, vs. 18% in 2000.

GlaxoSmithKline says 29% of its drug trials last year were outside the USA and Western Europe. In two years, that will hit 50%, it says.

Last year, 50% of trials for Wyeth Pharmaceuticals were outside the USA. That’ll be 70% in 2006, says Robert Ruffolo, Wyeth’s head of research.

Merck’s non-U.S. trials are at 50%, up from 45% five years ago, it says.

Cost is one factor. Trials in Eastern Europe, Asia and Central and South America might cost 10% to 50% less than trials in the USA and Western Europe, says Ronald Krall, GlaxoSmithKline’s head of development.

Researcher and clinic/hospital costs are lower and patient recruitment is faster, which also lowers costs. Bigger populations more in need of medical treatment make faster recruitment possible, Wyeth’s Ruffolo says.

The companies attempt to sell their drugs where tested, they say, and U.S. trials aren’t declining as much as foreign ones are increasing. Also driving the trend:

•Diseases. “We have to go where the action is,” says Henry Gabelnick of Conrad, a reproductive health agency. Next month, it plans to start a trial in four African countries and India to test a vaginal gel to prevent transmission of HIV/AIDS, which is more common in Africa and is rising in India.

•Regulations. Some nations, such as Japan, want drugs tested in their populations before approving them to be sold, says Fred Fiedorek, vice president of clinical research for Bristol-Myers Squibb.

Also, international standards for running clinical trials – including rules regarding consent – have been more widely adopted. The FDA expects companies to meet them, no matter where trials were done, to win approval to sell new drugs in the USA.

Unless there is a complaint, the FDA doesn’t inspect ongoing trials, either in the USA or outside. There are too many: an estimated 50,000 worldwide in 2003, says Thomson CenterWatch, which keeps a drug-trial database. Companies are required to monitor trials.

Violations occur. Since 1998, the FDA has tried to disqualify about 30 U.S. researchers from running trials because the FDA said they violated regulations.

With more foreign trials, “They’re further away from whatever scrutiny we have here,” says Vera Hassner Sharav of the Alliance for Human Research Protection.