Early in 2008, Judicial Watch initiated an investigation of a government sponsored organ procurement program. The program, known as Rapid Organ Recovery Ambulances (RORA), was administered in New York City and received funding from the Health Resources and Services Administration of the Department of Health and Human Services. As highlighted in a June blog series, the program breached ethical and medical standards, discriminately targeted minorities, and raised institutional credibility questions.

As part of its investigation, Judicial Watch sued the Fire Department of New York (FDNY) and reached a favorable settlement after FDNY obfuscated transparency by not disclosing related records. Following its publications on this dubious program, Judicial Watch continued to follow-up to receive the actual program data. Judicial Watch recently received some additional documents that further shed light on the program and demonstrate the power of public exposure.

Many of the program goals for which RORA was funded have yet to be met. As noted in a previous blog entry, the ethical White Paper that was slated to be written by February 2008 has yet to be written as of October 2009. According to HRSA's letter, data from the ambulance and procurement activities have yet to be gathered as “there have been no ambulance or EMS dispatches for rapid organ recovery.” On one hand, readers should be relieved that the program has yet to actually be put into action. On the other hand, however, the US government provided millions of dollars based on a proposal that was not fully carried out. The documents provided do not demonstrate that HRSA stopped funding RORA even after the White Paper was not provided. The documents further do not demonstrate where the money actually went.

Despite concern for HRSA’s oversight of its funding, the recently received documents provide a positive step resulting from the power of public interest and reporting. The December 2008 Quarterly Progress Report noted:

a debate ensued among ethicists and the media and government officials were concerned as well given the research was funded by HRSA.

given the recent climate surrounding the manner in which investigators may have breached ethical norms in other funded organ donation research projects, the new UDCDD protocol has a tripartite consent procedure where consent is obtained to initiate organ preservation first with automated chest compressions and maintaining of ventilation as heparin is administered to the deceased, followed by a second consent to allow percutaneous cannulation of the deceased and initiation of extra corporeal membranous oxygenation (ECMO) in the emergency department setting.  The third consent is for the donation to proceed with standard next of kin protocols established by the organ donation community.

These changes are rather significant and follow Judicial Watch’s lawsuit and reporting. The previous proposals did not provide tripartite consent in any fashion. Recall, that the previous procedure was described as preserving organs without consent consisting of possible mutilation and violations of religious and legal principles. Furthermore, The New York City Uncontrolled Donation after Cardiac Death Protocol July 13, 2009 draft began to address ethical concerns in a conciliatory manner.  The draft notes:

a LNOK or SIFM, if available, will be asked for verbal permission to proceed with organ preservation measures to afford the individual(s) time to consider donation as an option for their loved one (34).  The permissions requested at this time include additional physical examinations to determine UDCD program eligibility, the administration of heparin and thrombolytic medications, and then one minute of manual chest compressions to circulate the heparin and thrombolytic medications.

While the doctors involved with RORA have heeded public concern about their ethical standards, the public needs to remain vigilant about this program. A major goal of the program has been to obtain public approval to which end they hired Ogilvy Public Relations, an affiliate of Ogilvy Worldwide. Ogilvy Worldwide received over $10 million dollars thus far in 2009 for lobbying the government. The firm is quite adept at influencing the government and individuals, admitting “we understand public policy - who influences it and who decides it. We also understand how to communicate effectively about policy.” The survey followed a presentation (in which documents were not provided to Judicial Watch) and contained leading questions beginning with “New York EMS will make every attempt to save the patient’s life…” The RORA documents note a favorable public opinion towards the program, but given the firm hired and the survey format, any other outcome would have been unlikely.  

As we continue to monitor RORA and HRSA’s awarding of grants, the issues have not disappeared. When any government agency provides funding to a program, there should be accountability as to whether the program is ethical, discriminatory, meets high standards, and the money is used as proposed. It took a lawsuit to obtain records and significant media exposure to alter some of the ethical procedures in writing. Neither HRSA nor RORA, however, is off the hook as many of the problems from previous blogs have still to be rectified.  

Additional Documents

 February 2009 Manhattan Community Board Six Resolution (Expanding Opportunities for Organ Donation)