The clinical trial began in San Diego County on May 20, 2004, when a Mercy Air emergency-services helicopter, based at Gillespie Field, started carrying PolyHeme. On June 11, 2004, seven ground ambulances serving cities outside of the city of San Diego joined the trial. The ground ambulances are owned by a private company, American Medical Response, which serves 11 cities in the county as well as unincorporated areas. According to the company's spokesman, Devon Price, the ambulances participating in the study operate in National City, Chula Vista, Bonita, and Imperial Beach. Earlier this week, Hoyt, of UCSD, said six paramedic rigs outside the city of San Diego were equipped with PolyHeme.
But according to records obtained from the City of San Diego, at the time the U-T story appeared, city officials and UCSD administrators were still negotiating when and where the city's paramedics would use PolyHeme.
Northfield wanted to limit the PolyHeme trial to neighborhoods with the highest trauma rates. On May 2, 2003, Beth Romeril, the research coordinator of the UCSD study, wrote Hoyt, the principal investigator. "My biggest concern at this time is that in conversation with Bob McGinnis from Northfield on Wednesday, he indicated to me that Northfield would not have enough product to stock even the 12 or so ambulances in UCSD's catchment area, that part of the reason for the TREG [San Diego County Regional Trauma System Registry] search would be to identify the '3 or 4' ambulances that would be most likely to encounter appropriate patients.
"I have asked him to confirm the maximum number of ambulances they would be able to supply for us and waiting to hear back," Romeril wrote, adding that her geographic survey of trauma data was complicated. "Most of the time the location (zip code) where the encounter took place is not available, so we can't identify specific medic rigs in most cases."
At the City of San Diego, officials worried about possible lawsuits in case PolyHeme didn't work as advertised. They wanted to isolate the city's possible financial liability by demanding that the study's sponsor indemnify the city for $15 million against malpractice claims.
Why might there be malpractice claims?
By the very definition of the study, all patients are in hemorrhagic shock and unable to refuse the PolyHeme. As noted by Northfield: "It is expected that patients enrolled in this trial will be unable to provide informed consent because of the nature and extent of their injuries." The lack of consent was justified on the grounds that the existing blood substitute currently used by paramedics is simple saline solution and that almost anything, even an experimental substance like PolyHeme, would be an improvement for desperate trauma patients.
And there was another reason for the city to fear lawsuits. Even after arriving at the hospital, patients would not receive real blood.
The protocol called for trauma patients selected for the study to be randomly separated into two groups: the control group would get the standard saline as the resuscitative fluid; the experimental group would be infused with PolyHeme. When patients arrived at the hospital, those receiving saline would be switched to blood. But those receiving PolyHeme would continue to receive PolyHeme -- up to a maximum of six units -- for 12 hours after their injury.
Other medical centers were not as sanguine as UCSD about the PolyHeme trial and pulled out before it began. According to a letter from Northfield to Hoyt, dated last August 27, Milwaukee's Froedtert Memorial Lutheran Hospital's review board "has not approved conduct of the study at their institution. The letter from [redacted] cites this [review board's] position that once the patient is in the hospital, blood is not an unsatisfactory treatment, which is what is required for waived consent."
Boston Medical Center dropped out for similar reasons.
A study at the University of Southern California was shut down before it began, according to state records.
The City of San Diego moved forward with the trial in midsummer. In a memo dated August 10, 2004, the city's Emergency Medical Program manager, Donna Goldsmith, quietly informed the council that the PolyHeme trial would finally proceed. "Based upon previous trauma demographic data," the memo said, "it is projected that the San Diego region will contribute 40 patients to the study. The safety and efficacy of this artificial blood product have been demonstrated in several in-hospital studies involving more than 300 patients."
Goldsmith's memo went on to say that paramedic units in three of the city's poorest communities -- Oak Park, Nestor, and San Ysidro -- had been chosen for the trial because those areas generate the largest number of severe trauma patients, who typically are victims of car accidents and shootings. (A fourth paramedic unit, based downtown, would later be included in the study, Goldsmith said in a recent telephone interview, but that was not included in the memo to the council.)
"Specific ambulances and medic-engine crews have been selected to carry PolyHeme in specially designed coolers," the memo said. "The crews selected are those that frequently encounter major trauma victims within the catchment regions of the trauma centers participating in the trial -- UCSD Medical Center and Scripps-Mercy Hospital."
The units assigned to the PolyHeme trial -- Oak Park's Medic 26, San Ysidro's Medic 29, and Nestor's Medic 62 -- rarely venture from their home turf, Goldsmith said.
"Although PolyHeme will be placed on the engines and ambulances listed above, due to the fluidity of the EMS System, these resources could be assigned as needed throughout the City."
But under the terms of the study, paramedics could administer PolyHeme only if they were delivering the patient to the UCSD Medical Center or to Scripps Mercy Hospital.
The agreement did not go to council. It is dated September 28, 2004, and is signed by then-deputy city manager Patricia Frazier. The trial began in the city on November 19.
(In May of this year, Frazier, along with former treasurer Mary Vattimo and human resources director Cathy Lexin, quit her job in what was widely seen as a shake-up related to the city's festering pension-fund crisis. Lexin and Vattimo, former members of the pension board, were later charged with conflict of interest for their votes to allow underfunding of the pension system. Frazier was not charged.)