A vigorous, behind-the-scenes debate between the mayor's office and UCSD then ensued about the merits and risks of the trial -- a discussion that, had it been conducted in public rather than behind closed doors, would doubtless have been of interest to San Diegans.
E-mails obtained under the state Public Records Act show that from the very beginning of the university's attempt to gain the mayor's favor, researchers were shadowed by controversy from another UCSD trial involving an experimental blood substitute called PolyHeme.
As with the ROC study, the rules of the PolyHeme trial did not require that its subjects -- trauma victims who were comatose -- give their consent to the procedure, the infusion of PolyHeme, a concoction of synthetic hemoglobin and other ingredients that its proponents maintained would be better than saline solution at saving lives in the minutes before patients reached the hospital and received regular blood.
In the PolyHeme trial, which began in San Diego in May 2004, small plastic bags of the blood substitute developed by the trial's sponsor, Northfield Laboratories of Evanston, Illinois, were deployed in three of the city of San Diego's poorest neighborhoods on paramedic trucks: Oak Park's Medic 26, San Ysidro's Medic 29, and Nestor's Medic 62, as well as at the downtown fire station. Other paramedic units in the county and an air medical transportation service were also enrolled in the study.
The reason for restricting the initial deployment in the city of San Diego to the three low-income neighborhoods was that Northfield had provided UCSD with only limited supplies of the substance, according to a May 2003 e-mail by study coordinator Beth Romeril.
But neither UCSD nor San Diego officials ever made public the specific locations of PolyHeme deployment within the city. Instead, the university issued a press release, took out small newspaper advertisements to announce the trial, and held a public briefing in August 2003 at University Hospital in Hillcrest. It also provided plastic bracelets to be worn by people who did not wish to be given the blood substitute.
The trial received brief mentions on several TV news broadcasts and a March 23, 2004 story in the Union-Tribune headlined "A new hope for saving of lives," in which Dr. David Hoyt, then trauma director at UCSD Medical Center and principal investigator for the San Diego part of the study, touted the substance's potential and downplayed its risks.
But for those seeking to know how the trial was proceeding, the university was tight-lipped. It refused to provide information regarding the well-being of the subjects participating, arguing that doing so would violate a trade secret agreement it had signed with Northfield, the project's sponsor.
One example of the information gap was a heavily redacted letter dated August 26, 2004, from Daniel Masys, MD, then director of UCSD's Human Research Protections Program, to Hoyt concerning an "adverse event" -- a serious complication or death -- encountered by one of the study subjects and reported to the university's Institutional Review Board, a group set up under federal law to review the ethics and integrity of the university's medical research.
"Your July 22, 2004 adverse event report for Project 030443 has been reviewed and accepted by the IRB Committee at the August 2004 meeting. This report concerns the following subject: 1)."
The description that followed, describing the cause of the incident and what happened to the patient, was blacked out by the university. Hundreds of other documents requested by a reporter under the state's Public Records Act were similarly censored on the grounds that making them public would violate patient privacy or reveal Northfield's trade secrets.
And though UCSD repeatedly insisted that it wanted the public to be fully aware of the PolyHeme study and the ethical issues it raised, a June 21, 2005 e-mail showed that Romeril and Kelly, the coordinator of the upcoming ROC trials, were wary of fielding pointed media inquiries.
"Could you send me the name of the reporter that has been asking about PolyHeme and now ROC," wrote Kelly to Romeril. "I saw [Dr.] Danny Davis today and wanted him to know that this person was out there asking questions about ROC and PolyHeme with a history of stirring up trouble. He wanted more information i.e. what newspaper, what has he written in the past, 'have you googled him' etc.
"I just wanted Dan to be aware that if someone does start asking questions that he be sure that the intent was sincere and not malicious. Dan was more of the impression that reporting to the media was not necessarily a bad thing. I agree but would prefer it be in a good light with positive spin rather than someone just looking for dirt to stir up."
Romeril replied the same day: "The reporter is Matt Potter, an 'investigative reporter' for the Reader here in town. You can look at the Reader web site to see stories he has had printed in the past -- they tend to be long, wandering exposé types about possible corruption in city government....
"He is not a science or medical reporter and he is definitely not looking for good news to share. Also be aware that there are legally binding confidentiality agreements in place with Northfield regarding this study, and rest assured we will be sued (by Northfield) if we breach that contract, so check with them before saying anything to a reporter!"
Concluded Romeril: "In general, media attention is not a bad thing; in fact Channel 10 is planning a follow-up piece for some time in July. Dr. Hoyt will be interviewed for that again. The problem with Mr. Potter is that he seems to be on a fishing expedition and just wants carte blanche access to all sorts of study files etc. without giving any kind of reason or explanation as to what it is he is looking for...does not inspire confidence in his motives!"
A month later, in a brief July 2005 interview, Hoyt defended the PolyHeme trial, saying that it was safe for its subjects and fully compliant with federal regulations that cover drug trials involving lack of informed consent. He also minimized the adverse event report, but he would not describe what had happened to the patient.