Wednesday, July 08, 2009
Globalization Effect of the Day: Testing our drugs abroad
In 1997, approximately 86 percent of FDA-regulated principal investigators were based in the United States, but just 10 years later, only about 54 percent of the roughly 26,000 chief scientists who conducted clinical trials were based here....
Does anyone get the irony here? While American consumers are warned by the FDA not to buy drugs produced in other countries, the safety and effectiveness of the drugs are being tested in these very countries.
Fortunately there's a simple explanation for this contradiction: Both are done to maximize the profits of the drug industry without regard to the well-being of the American public.
In addition to the concerns raised by the authors of the study, it should be mentioned that outsourcing denies to U.S. patients the opportunity to participate in phase 3 trials (typically the final trial of a drug's efficacy before it is put on the market). This may be important because (1) the patient in a drug trial is given access to care that would otherwise be denied if the patient lacks health insurance, or (2) the patient may be given access to a drug that is not yet available and from which the patient may benefit.