2 SFBC execs quit as Sen. Grassley seeks answers in alleged mistreatment of subjects.

WASHINGTON--Just before U.S. Senate investigators questioned two former executives of pharmaceutical testing company SFBC International on Jan. 11 as part of their investigation into an alleged case of unsafe testing practices involving human subjects, one quit and the other retired.

Senate Finance Committee Chair Charles Grassley (R-IA), who has been probing FDA and clinical trials matters for more than a year, noted that his staff interviewed Lisa Krinsky, who then resigned as SFBC's president and chair, and Gerald Seifer, the company's former legal affairs director. Jeffrey McMullen replaced Arnold Hantman, who retired as chief executive, but it was unclear whether the retirement was related to Grassley's probe.

But Krinsky quit her position just before she was to be interviewed by Senate investigators looking into the company's testing practices at its Miami trial center.

"My staff informed me that they cooperated fully and that the interviews were productive," Grassley said. "The committee will continue reviewing the company's practices and activities."

The company has been in trouble since media reports surfaced in November that the firm's testing practices were putting patients' health at risk. The company said a report by an independent legal counsel refuted the allegations in the media stories.

The report was forwarded to Grassley and discussed during the Jan. 11 staff interviews, Grassley said.

The changes in leadership at the firm are part of an effort to regain investor confidence after officials in Miami forced SFBC to take out beds in its main trial center because of safety issues.

The senator also requested documents from U.S. regulators on inspections of SFBC. Rebecca Kujawa, an analyst at Stanford Group in Florida, said the changes were "enormously positive for the company."

Grassley's interest in the issue goes back to Nov. 17, 2005, when he sent a letter requesting a meeting with the CEO of SFBC to discuss the allegations. In mid-December, SFBC delivered a report to Grassley that disputed some of the allegations, the senator said.

However, the report also revealed that some behavior of SFBC personnel was "inappropriate," Grassley added. In response, Grassley sent another letter to SFBC seeking additional in-person meetings with top SFBC officials, including the director of legal affairs. The finance committee was subsequently informed that SFBC's director of legal affairs had recently resigned, Grassley said.

Company spokesperson Michael York said in a statement that the company was cooperating with Grassley's investigation. "We're pleased that the Senate staff found the meetings were productive," he added.

"The company believes these are important issues, and it is committed to the ethical treatment of participants in trials," York said.

Also, a Jan. 10 press release on the firm's website stated: "A regulatory task force led by Gregory Hockel, Ph.D., SFBC's senior VP of regulatory affairs worldwide, is responding to [the allegations about the Miami facility]. The task force will continue working closely and openly with all parties in an attempt to get these issues resolved. It is important to note that no warning letter has been issued."

The press release also noted that the SEC had requested records relating to the duties, compensation and expenses of Krinsky and Seifer.

By Joseph Pickett, Managing Editor