Stroke Treatment Studies Conflict : Medicine: A Scripps Clinic doctor contends that UCSD’s failure to coordinate similar research could harm stroke patients.
UC San Diego’s announcement of a countywide stroke treatment project brought a swift and angry reaction Friday from a Scripps Clinic doctor who contends that UCSD’s failure to coordinate the study with Scripps could harm stroke patients.
The doctor, Gregory L. del Zoppo, is planning a similar study under the auspices of Genentech Inc., the maker of the anti-clotting drug, tPA, that both San Diego projects will test. The drug currently is approved for use only in heart attacks.
Del Zoppo said that because the two hospitals have somewhat different guidelines for giving tPA, patients could mistakenly go to one hospital expecting to receive the drug and then not get it.
In addition, although Del Zoppo minimized this aspect, the institutions will be “competing” for patients who must meet very strict criteria to participate in either study. An earlier joint Scripps-UCSD test of tPA yielded only nine stroke patients who qualified.
The “dueling studies” saga becomes even more complicated in the case of Scripps Memorial Hospitals, which plans to merge with Scripps Clinic Jan. 1 but is listed as a participant in the UCSD trial.
Since the U.S. Food and Drug Administration has ruled that hospitals cannot participate in both trials, Del Zoppo said, that would put Scripps Memorial in conflict after the merger.
A Scripps Memorial spokesman said doctors there are aware of plans for the Scripps Clinic/Genentech study.
“We were approached by the clinic close to a year ago to participate in their study. We at that time declined because we had already made a commitment to participate in UCSD’s,” said Michael Dabney. “Obviously this was well in advance of the merger announcement.”
The drug, tissue plasminogen activator, is a clot-dissolving substance that has been controversial ever since it was approved for use against heart attacks in 1987. One of the first major products out of Genentech, it carried with it the company’s financial hopes for the future.
But by last year, tPA had been shown to be no better against heart attacks than a much cheaper drug, streptokinase. One dose of tPA costs $2,200. Its use has leveled off, according to company sales figures.
The San Diego chapter in tPA’s troubled story began Friday morning, when Del Zoppo said he learned of the high-profile UCSD study by reading about it in The Times.
On Thursday, Dr. Patrick Lyden, of UCSD and the VA Medical Center, had announced a $338,000 study funded by the National Institutes of Health. The study will give tPA to at least 26 stroke patients at several San Diego hospitals over the next three years, to see if it prevents brain damage.
Del Zoppo said the announcement surprised him not only because it included no mention of the planned Scripps effort, but also because he had talked with a UCSD official two weeks ago to try to coordinate the two studies.
He said he talked with Dr. John Rothrock, head of the UCSD Stroke Center, and they agreed to set up a meeting toward that end. Del Zoppo said he was waiting to call Lyden about a meeting date, however, until after a meeting in Chicago next Tuesday at which the Genentech study outlines will be discussed.
Rothrock was out of town and could not be reached for comment, but his secretary confirmed that Del Zoppo had made several calls to Rothrock over the last month.
Meanwhile, Lyden was finalizing his own plans for a community announcement of the stroke study, since an important component of it is educating San Diegans to seek medical help early for stroke symptoms.
But those plans proceeded without knowledge that Genentech-funded clinical trials were firming up. Lyden said Rothrock told him of talking with Del Zoppo, but never gave him the understanding that the Genentech trials were on.
“Frankly, I didn’t think they were going anywhere, so I didn’t contact (Del Zoppo),” Lyden said. “And now in retrospect I wish that I had contacted him when I didn’t hear from him.”
Lyden noted that at an Aug. 20 FDA hearing on tPA he came away with the clear impression that the FDA might not even approve Genentech’s study plan.
The net effect of the lack of communication was an angry Del Zoppo, who gave vent to competitive disgruntlement in an interview Friday morning.
“This is not the first time this has occurred,” he said. “It’s not the first time that we have had a situation in which UCSD has been involved in a project we have directed, and has simply taken credit for it, on one hand. And, on the other hand, has given to the press information that is misleading.”
Saying he was “chagrined” at the situation, Lyden had called Del Zoppo by midday Friday to offer a peacemaking meeting between the two study groups.
Del Zoppo said he fears that lack of coordination between the UCSD and Scripps studies could lead to confusion among the public. He also points out that there would be markedly different access to tPA depending on the hospital and study.
The UCSD study aims at giving tPA to suspected stroke patients 90 minutes to 3 hours after their first symptoms. The Scripps-Genentech study would take patients as long as six hours after symptoms began, Del Zoppo said.
So a patient who qualified for the six-hour study who showed up at a three-hour-limit hospital wouldn’t have that option, Del Zoppo said.
Lyden agrees that, if there is a chance for tPA access and a patient qualifies, it would be best if it were provided. But research, not access for individual patients, is the key objective, he said. No matter whether there are one or two studies, not everyone in San Diego County will have access to tPA.
“If you ended up at Grossmont, you wouldn’t be able to get it anyway,” Lyden said. “Whereas if you ended up because of blind luck at UCSD or Sharp Memorial you would get a chance at tPA.”
