CLINICAL TRIALS: President Proposes Fines for Violations

      Responding to the intense public scrutiny of human medical experiments, the Clinton administration today called for the authority to fine scientists up to $250,000 for violating federal rules and slap the research institutions that employ them with as much as $1 million in penalties, the Washington Post reports. The proposed fines, part of a broad plan unveiled by HHS Secretary Donna Shalala to tighten controls on scientists who perform human medical trials, come after recent government investigations"revealed hundreds of lapses" in clinical experiments nationwide. "Investigators and institutions need to know that when they deviate from accepted practices, there are consequences," Shalala said, adding: "What's at stake is the integrity of research, public confidence in that research and the integrity of the institutions as well as researchers all around the country." In addition to the monetary penalties, which require congressional approval, Shalala announced several immediate reforms, including improved training for review boards, greater assurances that patients understand risks and increased monitoring of patients during the early phases of the clinical trial process.

Cheers and Jeers
      Nils Hasselmo, president of the Association of American Universities, applauded the plan: "It is a positive proposal because it provides for something between an admonition and the death penalty," he said. Sen. Bill Frist (R-Tenn.), who has scheduled a Thursday hearing on patient safety during research experiments, also called the move "a step in the right direction." But he raised concerns about the proposed civil penalties. "[I]t strikes me as somewhat premature to create civil monetary penalties before fully assessing the current federal guidelines and regulations," he said (Kaufman, 5/24). Although the drug and biotechnology industries "generally support" the new proposals, the issue of fines "could be dicey," the Wall Street Journal reports. While the FDA now can levy monetary penalties in limited circumstances, efforts to expand that power previously have failed before Congress. Industry representatives will likely protest the new initiative. "I think the bottom line is that FDA already has some significant power, and it's not clear any additional authority is necessary," Lisa Raines, senior vice president for Genzyme Corp., said. "Already, they can shut you down if you don't comply, and that threat alone is enough to get any responsible manufacturer to do the right thing," she added (Adams, 5/24). Some academics criticized the proposal as well. "It's radical and it's inappropriate. It will drive people out of doing clinical research and ... cause a great deal of chaos," Dr. Gerald Levey, dean of the medical school at UCLA, asserted. According to Georgetown University bioethicist Dr. LeRoy Walters, without proper funding for the review boards that evaluate and approve human experiments, the new initiatives "will be of little use" (Stolberg, New York Times 5/24). But Vera Hassner Sharav, an activist with Citizens for Responsible Care and Research, said that the reforms do not go far enough. "Public confidence in clinical trials has been shaken ... This directive hardly tackles that major, fundamental issue," she said (Washington Post, 5/24).