This is a big feature story, so here is my longish lede:

Deciding whether to participate in a clinical trial is not easy, no matter where the study takes place. Patients are faced with a mountain of information about the potential risks and uncertain benefits of becoming research subjects.

Add to that heady brew the stark disparity among patients in rich countries and those in developing nations, and concerns mount quickly about the growing number of global clinical trials tapping the poor as research subjects.

Compare, for example, the United States and India.

The average American income is $47,000 a year — 16 times what the average Indian takes home, according to the CIA World Factbook. There is one doctor for every 384 Americans, while there are 1,667 patients for each Indian doctor, the World Health Organization says. The average American patient consumes nearly $7,000 in medical care each year; the average Indian’s annual health care tally is $39. Nearly every American adult can read, but 39% of Indians are illiterate.

What does it mean for research subjects around the world to give informed consent when the playing field is so uneven?

The whole shebang.

My lede:

A 2006 Archives of Internal Medicine study of 725 million prescriptions found that about one in five orders was written off-label — that is, for a condition that has not received the Food and Drug Administration’s approval as a safe and effective use of the drug. More than 70% of these off-label prescriptions were for indications in which the drug ordered had little or no scientific support.

The results of a new survey in the Aug. 21 Pharmacoepidemiology and Drug Safety add more cause for concern, experts said. Four in 10 doctors queried about 22 medications believed at least one of the drugs was FDA-approved for a given indication when it was not so labeled and lacked scientific evidence backing the prescribing decision.

The whole shebang.