Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According to its website, ORI “oversees and directs Public Health Service (PHS) research integrity activities,” including the integrity of research projects funded by agencies such as the National Institutes of Health (“NIH”) and the Centers for Disease Control and Prevention. ORI’s primary functions include such tasks as “monitoring” investigations that research institutions conduct when there are allegations of data falsification, and proposing administrative actions against medical researchers found to have fabricated the results of their studies.
In a world in which massive civil and criminal health care fraud cases have become almost routine, ORI’s authority and role appear decidedly modest. In fact, although ORI’s website lists seemingly egregious “case summaries” of research misconduct dating back to at least 2008, those same case summaries show that individual scientists who falsified critical research data have managed to settle with ORI by agreeing to exclusions from government contracting for limited periods of time, or, in some instances, through the still lesser penalty of having their research “supervised” pursuant to ORI-approved plans. Against the backdrop of the decidedly more aggressive enforcement actions that have come to the fore in health care cases, it is hardly surprising that ORI’s regulatory role has thus far attracted little notice.
Recently, however, ORI has become the focus of attention far exceeding anything it previously encountered. In fact, two recent developments have cast a bright and valuable spotlight on ORI and its functions.
The first indication of the heightened attention being given to ORI arose on February 10, 2014, when Senator Charles Grassley (R-Iowa) sent ORI a letter inquiring about a specific case of research misconduct at Iowa State University. The case involved research into experimental HIV vaccines, and in particular, the discovery that one of the project’s scientists improperly injected test animals with human antibodies to create the false appearance that the vaccines had created resistance to certain strains of HIV. Senator Grassley’s letter asserted that the HIV vaccine project had received NIH grants totaling $19 million, and that the researcher’s acts of misconduct had resulted in these substantial government awards. Senator Grassley further noted that in December 2013, ORI entered into a resolution with the researcher in which the penalties consisted of only a three-year ban on receiving federal contract funds and advising the Public Health Service. Observing that “[t]his seems like a very light penalty for a doctor who purposely tampered with a research trial and directly caused millions of taxpayer dollars to be wasted on fraudulent studies,” Senator Grassley went on to ask a series of pointed questions about the HIV vaccine research project in particular, and ORI’s practices in general. Most notably, Senator Grassley inquired whether ORI had done anything to attempt to recoup the $19 million in federal grant money that had been used to fund the fraudulently-conducted research, and whether ORI had referred information about the research fraud to “any other government agency for further inquiry” – meaning, presumably, whether ORI had referred the matter for criminal prosecution.
On March 5, 2014, the Acting Director of ORI responded to Senator Grassley’s letter with a six-page letter of his own. With respect to the question of whether ORI had attempted to recoup the funds provided for the fraudulently-conducted study, ORI’s letter did not address whether any such recoupment efforts had been made. Instead, ORI explained that HHS “may seek to recover. . . funds spent in support of activities that involved research misconduct,” but then indicated that because ORI actions are against researchers rather than institutional recipients of government funds, ORI’s role is limited to notifying the agencies that provided the funds in question (in this case, NIH) so that they can decide whether to seek recoupment. Regarding the question of whether ORI had referred its findings of fraudulent research to any other government agency, ORI’s letter indicated that notification had been made to NIH, but did not discuss whether there was also a criminal referral. Given the nature of these answers, it is perhaps not surprising that a spokesperson for Senator Grassley criticized ORI’s response, asserting that ORI had not answered many of Senator Grassley’s questions.
The second recent development relating to ORI was in some ways even more striking than the first. On February 25, 2014 – just over two weeks after the date of Senator Grassley’s inquiry letter – David Wright, who was then the Director of ORI, sent a remarkably caustic resignation letter to HHS’s Assistant Secretary for Health. In that resignation letter, which was provided to Science magazine and published on March 12, 2014, Dr. Wright lambasted what he referred to as the “remarkably dysfunctional HHS bureaucracy,” complained about a lack of resources, and labeled the Office of the Assistant Secretary for Health (under which ORI operates) as “secretive, autocratic and unaccountable.” Dr. Wright’s resignation letter further questioned whether the structure of HHS causes ORI to operate in an “intensely political environment” that undermines its proper functioning. Finally, as if his comments were not already dramatic enough, Dr. Wright concluded his letter by announcing his plan to publish a “daily log” that reflects his “experiences and observations” as the director of ORI.
What, then, to make of all this sturm und drang surrounding ORI? The most obvious answer is that in the short term, the agency appears to be in turmoil, attacked from within and scrutinized from without in a way that can only make its functioning more challenging. But the larger question here is whether ORI will respond to the criticisms it has faced by adopting an increasing degree of aggressiveness, be it through more criminal referrals, heightened efforts to claw back research funds, or otherwise harsher penalties. For medical researchers accused of misconduct, the institutions for which they work, and the attorneys who represent them, the answers to these questions may well prove critical.
(Photo credit: PAHO/WHO)