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San Diego — Polyheme update In an attempt to prevent further publication of information about the testing of its controversial blood substitute Polyheme in San Diego, Chicago's Northfield Pharmaceuticals has filed suit against the Reader and its publisher, James Holman, alleging that documents the County of San Diego provided to the paper this past summer in response to a California Public Records Act request constitute "trade secrets."

In a cover story, "Bad Blood?", published July 28, this newspaper reported that Northfield had entered into an agreement with UCSD and San Diego city paramedics as part of a national trial of Polyheme, a plasma substitute for which the company is seeking FDA approval. Under rules of the trial, the substance is administered only to subjects who are comatose as a result of traumatic injuries, such as gunshots and traffic accidents, and therefore are not able to give their consent or permission.

Though the university maintained that it had complied with federal requirements to fully notice the community about significant details of the trial in its midst, the newspaper revealed that -- according to a memo to the San Diego City Council from Emergency Medical Program manager Donna Goldsmith, obtained under the Public Records Act -- the deployment of Polyheme on San Diego city paramedic units was being limited to the downtown area and three predominantly blue-collar, minority neighborhoods: Oak Park, Nestor, and San Ysidro.

"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 memo said.

According to a May 2, 2003, e-mail from research coordinator Beth Romeril obtained from UCSD under the Public Records Act, Northfield wanted to limit the trial to high-trauma areas because it did not have sufficient Polyheme for citywide deployment.

"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," Romeril wrote. Study director David Hoyt, M.D., of UCSD later confirmed that the limited deployment was a "cost containment" issue.

Although UCSD partially complied with the paper's request for documents, it redacted large amounts of information, including the details of two "adverse event" reports regarding the trial, claiming in part that its trade-secret agreement with Northfield prohibited release. The Reader subsequently sued the university under the Public Records Act to obtain that information, and earlier this month Northfield intervened in the case. Then, in a letter to the paper's attorney, William Sauer, dated December 20, a Northfield attorney alleged that "Northfield's trade secret information is contained in unredacted documents produced to Mr. Holman by the County of San Diego, Emergency Medical Services pursuant to your CPRA request, including (i) the unredacted Research Plan, (ii) the Global Investigative Product Handling and EMS Plan, (iii) the TRBSE-11-(N) Treatment and Assessment Algorithm, and (iv) the unredacted PowerPoint presentation entitled 'PolyHeme® Trauma Trial.'

"Please consider this a request that Mr. Holman and the Reader stipulate not to disclose or use any of Northfield's trade secret information, including publishing such information in the Reader either permanently or at the very least until the hearing in the Holman lawsuit on February 3, 2005 [sic]," the letter said. "I further request that all copies of documents containing Northfield's trade secret information be returned and that you provide copies of responses from other institutions to the Reader's other CPRA requests."

The next day, without notice to the newspaper, Northfield obtained an ex parte hearing before San Diego Superior Court Judge Joan M. Lewis, who granted the firm a temporary restraining order barring publication of any of the information obtained under the Public Records Act that Northfield regards as a trade secret. The order also required Holman to turn over "all documents in his possession, custody, or control containing Northfield confidential information." Lewis set a hearing on a permanent order for January 13.

"We will vigorously contest this sweeping order and its chilling violation of the First Amendment's prohibition against prior restraint," Holman said in a written statement. "Our Public Records Act requests were made within the law and as a result of our duty as a newspaper to provide the public with important information being maintained by taxpayer-funded public institutions.

"Our July cover story 'Bad Blood?' has already revealed missing links in the way the Polyheme trial has been conducted in San Diego," Holman continued, "and it has generated public discussion regarding the ethics of nonconsent medical studies. Clearly the public interest weighs heavily on the side of further disclosure of public records regarding this secretive trial.

"This unjustifiable encroachment into the prerogatives of a free press protected by the First Amendment is even more egregious in that Northfield is using public facilities to further its commercial agenda. We are mindful of the trade secrets law, as we assume was the County of San Diego in disclosing to us this information, and we have acted and will act responsibly in reporting this significant story, in the manner our readers have come to respect. The last thing this community and the nation as a whole needs is to have courts telling newspapers what they can print before publication. Just as bad is the notion that a court can issue an order permitting a corporation to delve into the confidential work product of a free media. This order must not stand."