Should've asked for a second opinion.

• Position: Medco Research Inc.'s research on drug BiDil rejected by FDA

Medco Research Inc. has learned Uncle Sam can prescribe a bitter pill. The company claims it followed to the letter Food and Drug Administration guidelines to bring to market BiDil, a new drug for heart congestion that analysts figured would ring up $60 million in annual sales.

"Then the FDA said: 'We have the right to change our mind. You don't,'" analyst John Boettiger says.

In late February, an FDA advisory committee ruled that the statistical sample showing BiDil's effectiveness was too small. Two statisticians on the committee contradicted advice the FDA staff gave Medco. That day, the company's stock tumbled from $13 to $9.69. It was already languishing well below its high of $33 in 1990, before President Clinton's attempt at health-care reform and Medco's failed acquisition of Repligen, a Cambridge, Mass., company.

The FDA won't let Medco add to the study, so it would have to start over. That could take four more years and millions more dollars. Roger Blevins, the Research Triangle Park-based company's CEO, won't say how much Medco spent getting the drug to this point. Industry sources put it at about $8 million. The company expects to decide in June whether to scrap BiDil. "The frustrating part was that all along, we'd worked with the FDA and did...