From: 23x11.5c@gmail.com   
      
   3/20/2014 @ 11:53AM   
      
   Medical Research Fraud And HHS's Office Of Research Integrity: Watching The   
   Watchdog   
      
   Robert Radick Robert Radick , Contributor   
      
   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 fr   
   udulently-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.   
      
   JD%2520PAHO%25202010%2520-%2520027%2520%25282%2529   
   (Photo credit: PAHO/WHO)   
      
   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 f   
   audulently-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.   
      
      
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