Wednesday, December 28, 2005

Some Consequences for SFBC International

We have posted frequently about the troubles of SFBC International, a for-profit clinical research firm.

Last month, we posted about allegations that private, for-profit clinical research firms, including SFBC International, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that SFBC International had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices. Furthermore, we discussed how a review commissioned by the company found that a top executive, Jerry Seifer, SFBC International's Vice President for Legal Affairs, threatened participants in clinical studies who had talked to the press with deportation. Seifer, it turns out, had been the subject of past regulatory sanctions by federal regulators. In addition, study participants in a trial of an immunosuppressant drug carried out by the firm's Canadian subsidiary, SFBC Anapharm, acquired tuberculosis after exposure to another participant with active disease, despite their complaints to Anapharm staff.

There have been some consequences for all this. The South Florida Business Journal reported that Seifer has resigned, although SFBC International gave no reason for his departure. Also, the Miami Herald reported that the company has hired investment banks "to explore strategic alternatives," which the newspaper suggested meant looking for buyers for the firm, whose stock price has dropped from $41 to $15.

Commercial research firms are carrying out an increasing proportion of clinical research. Doctors and patients depend on such research when making decisions about which tests and treatments to employ. Thus, the troubles of SFBC International, a major player in the commercial clinical research world, raise yet another set of worries about the integrity of clinical research.

However, although these troubles have attracted the attention of legislators and investors, they have caused few ripples in health care circles. The anechoic effect lives.

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