Most medical delivery systems, including treatment in the California workers’ compensation program, have evolved to payment only for “evidence based” medicine. High quality medical science is supposed to be used to approve or disapprove UR and IMR treatment requests. Consequently, there needs to be some oversight of the medical science. Gatekeepers are needed who will scrutinize supposed medical science for foul play. As simple as that sounds, there are frustrating bureaucratic hurdles to overcome at the highest levels of federal government.

The director of the U.S. government office that monitors scientific misconduct in biomedical research has resigned after 2 years out of frustration with the “remarkably dysfunctional” federal bureaucracy. David Wright, director of the Office of Research Integrity (ORI), writes in a scathing resignation letter that the huge amount of time he spent trying to get things done made much of his time at ORI “the very worst job I have ever had.”

ORI, which is part of the Department of Health and Human Services (HHS), monitors alleged research misconduct by researchers funded by the National Institutes of Health (NIH) and other Public Health Service (PHS) agencies. It runs education programs and reviews institutions’ misconduct investigations, each year posting a dozen or so findings of misconduct, defined as fabrication, falsification, or plagiarism. It also recommends PHS sanctions, such as barring researchers from receiving grants. ORI’s visibility has grown recently along with a rise in retracted research papers, some involving misconduct.

Observers lauded Wright’s appointment in December 2011, which ended 2 years in which the office had no permanent director. Wright, a historian of science at Michigan State University in East Lansing, had served as an ORI consultant and came in with plans to beef up training programs. But last February, he fired off a fiery resignation letter to his boss, HHS Assistant Secretary for Health (ASH) Howard Koh.

In his letter, David Wright writes that working with ORI’s “remarkable scientist-investigators” was “the best job I’ve ever had.” But that was only 35% of his job; the rest of the time he spent “navigating the remarkably dysfunctional HHS bureaucracy” to run ORI. Tasks that took a couple of days as a university administrator required weeks or months, he says. He writes that ORI’s budget was micromanaged by more senior officials, and that Koh’s office had a “seriously flawed” culture, calling it “secretive, autocratic and unaccountable.” For example, he told Wanda Jones, Koh’s deputy, that he urgently needed to appoint a director for ORI’s division of education. Jones told him the position was somewhere on a secret priority list of appointments. The position has not been filled 16 months later, David Wright notes.

OASH itself suffers from the tendency of bureaucracies to “focus on perpetuating themselves,” David Wright writes. Officials spent “exorbitant amounts of time” in meetings and generating data and reports to make their divisions look productive, he writes. He asks whether OASH is the proper home for a regulatory office such as ORI, noting that Koh himself has described his office as an “intensely political environment.”

David Wright makes no mention of a recent letter to ORI from Senator Charles Grassley, who has complained that ORI was not tough enough on an AIDS researcher at Iowa State University who faked data to obtain nearly $19 million in NIH funding. ORI barred the researcher, Dong-Pyou Han, from participating in PHS-funded research for 3 years, but Grassley has asked why ORI did not make him return federal grant money or impose harsher sanctions.