UW Medical Struggles to Wag the Dog

Starting in May 2004, some emergency patients were given a blood substitute called PolyHeme, being developed by Northfield Laboratories in Evanston, Illinois. But on December 19, 2006, preliminary results from clinical trials showed a devastatingly poor performance--the mortality rate for patients receiving PolyHeme was 13.2 percent, versus 9.6 percent for patients receiving traditional treatments.

Now, at this point we have to stress that PolyHeme is not being tested by ROC at the UW. Of the three experimental treatments being tested on patients headed for Harborview, the closest is a product called Rescueflow, a blood volume substitution given to trauma patients, created by Biophausia, a Stockholm-based pharmaceuticals company, and already registered in 14 European countries. A number of clinical tests have been run on Rescueflow in Europe, and none show any negative benefit to patients--in fact, it seems to have virtually no benefit over traditional treatments except a slight one for patients with head injuries and penetration trauma. Its primary appeal seems to be for military applications, since it can be used in place of higher volume substitutes and is therefore easier to transport.

But the PolyHeme case does demonstrate the very real risks experimental test subjects undergo, in this case without having been informed or having had their consent sought. PolyHeme was a product that made it to human trials, exempted from informed consent, that was an unqualified disaster, drawing into question the contention that there's so little risk involved in these experimental treatments that we shouldn't worry about it. And what's more, we think it should remind researchers that they have a serious social and ethical obligation to go out of their way to inform the public in no uncertain terms that they may be subject to experimental treatments which could, in fact, be less effective than existing ones.

But we see precious little evidence that the ROC is making a good-faith effort to educate the public; in fact, in the San Diego case, they displayed a good deal of hostility to any potentially unfriendly press. In emails uncovered by public information requests filed by The San Diego Reader, it turned out that Donna Kelly, the coordinator of the upcoming ROC study, discussed being wary of the press with Beth Romeril, the coordinator of the PolyHeme trial. As Potter reports:

"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."

That last comment seems to sum up the medical community's response to anyone who questions the wisdom of running potentially dangerous tests on subjects without their knowledge: a desire to publicly minimize the risks and play up the benefits, always putting themselves in a good light. In other words, instead of public education, they're engaging in spin-control.

And here in Seattle, they have good cause. It turns out, the University of Washington doesn't have as stellar a record of human testing as one might expect from an institution being entrusted to test without seeking prior consent. In April 2005, the Office for Human Research Protections, a division of the US Department of Health and Human Services, issued a fairly damning report based on a February 2005 "not-for-cause on-site evaluation of the University of Washington's (UW) system for protecting human research subjects." (Follow this link for the page archiving it and its response on the UW's website.) The report found that the Institutional Review Board (IRB) responsible for approving all studies "often seems reluctant to defer approval of a study," instead approving them "contingent upon receipt of additional information" at a later date. Additionally, the UW's IRB was found to have poor record-keeping, to have failed to conduct required yearly reviews of ongoing studies, to have misused private patient information, to have failed to establish reporting guidelines in writing for required reporting, and, amongst other complaints, to have failed to follow established procedures when running tests on prisoners. A number of measures to rectify the situation were proposed in late 2005.

As for the ROC's public information campaign here in Washington, it seems to have been perfunctory at best. Instead of publishing notices in either the Times and P-I, as would seem to be common practice, the researchers instead wrote editorials to the papers, assuming the op-ed section could be used for their purposes. Neither were published. Instead, as they told Seattlest in an interview, they bought cheaper ads in Real Change and NW Asian Weekly that ran in late October and early November 2006. Their press releases hit the local dailies and radio shows, but avoided both The Stranger and Seattle Weekly, the two largest Seattle-area weeklies. Honestly, we're not sure what to make of their misguided attempt at educating the public. The reliance on trying to get the press to pick up the story, rather than simply publishing paid announcements, is consistent with the impression that they're more interested in spin than public education, attempting to neutralize media criticism by engineering positive coverage first. On the other hand, the less than rigorous approach fairly successfully doomed the program to public obscurity, which may have been more or less the desired effect. "Soft launching" the program on the public served to keep uncomfortable questions from being asked, which is why we're only talking about this nine months after the majority of their efforts were undertaken. Whatever else, it was definitely cheaper than publishing any real announcements--according to what they told Seattlest, they paid for an ad to be run all of five times in two small circulation magazines.

Then there's the "No Research Study" bracelets that, supposedly, concerned members of the public can request. Despite the fact that the ROC study has been controversial at virtually all of the 10 regional clinical centers where research has been conducted, Carol Ostrom's article found the UW researchers unprepared for the publicity it generated and the demand for opt-out bracelets. Last weekend, researchers were responding to emails and press inquiries (including Seattlest's). As for requests for the bracelets, they seem to have been handled in a rather confused fashion. The friend of Seattlest who originally put us on this story had to exchange several emails before receiving confirmation that a bracelet was being sent. Yet when it arrived earlier this week, it was not the promised metal bracelet, but rather a rubber band with "ROC" impressed upon it, and the words "No Study" written on by hand in magic marker (see above picture). The letter in which it arrived promised that the actual bracelet will be sent when more are available.

Now, we're not accusing the ROC researchers at the UW of malign intent; at best, their behavior suggests a disappointing lack of preparedness, and at worst, general incompetence. And we don't want to smear their work with the PolyHeme debacle, something they had nothing to do with. But we have serious doubts about their good-faith efforts when people like Dr. Graham Nichol, the ROC medical director at the UW, writes angry letters to the editor making statements such as the following:

Each ROC trial was reviewed by multiple independent groups before startup: a protocol review committee, a data safety monitoring board, the Food and Drug Administration and institutional review boards (IRB). This process includes consultation of the community. All citizens concerns are reported to the IRB. An IRB can require a change in the design of the study or even not allow the study to enroll patients in their local area.

What the PolyHeme debacle shows is that despite the safeguards organizations try to put in place, outcomes can be bad for the unknowing guinea pigs. So when an organization "soft launches" their study, demonstrates hostility to uncomfortable questions, has a questionable track-record with human testing, and turns out to be woefully unprepared to respond to legitimate public concerns, we think we can be excused from offering them our unconditional trust.