Blood substitute raises questions

Hopkins physician nixes planned report because of lack of data


Johns Hopkins Medicine took the unusual step yesterday of announcing that one of its physician researchers has canceled a planned report about a controversial blood substitute at a scientific meeting next month.

Dr. Edward Norris, the university said, did not receive all the data he needed from the manufacturer to make a presentation on the blood substitute PolyHeme, which is the subject of congressional and Food and Drug Administration inquiries.

The inquiries surfaced after The Wall Street Journal reported late last month that 10 patients who received PolyHeme had suffered heart attacks within seven days, and that two had died.

Although PolyHeme's manufacturer closed that clinical trial in 2000, the company never published those results.

Despite the deaths, the Journal noted, manufacturer Northfield Laboratories Inc. was proceeding with a new clinical trial - one testing PolyHeme in trauma patients who are often too badly injured to consent to their participation.

Hopkins is not involved in that clinical trial, and Norris said yesterday that none of the 43 Hopkins patients enrolled in the earlier trial - which involved elective surgery - suffered heart attacks.

Even so, Hopkins' Norris has wound up ensnared in the controversy, partly because Northfield had defended itself by invoking his name and the work of an independent safety monitoring board on which he serves.

PolyHeme is one of several experimental blood substitutes being tested as an alternative to donated blood.

Scientists say traditional donor blood can be a source of infection, can lead to complications when it's not properly type-matched and is problematic to administer on battlefields or other remote sites, in part because it must be refrigerated.

In a release late last month, the company said Norris was the lead investigator on the trial that closed in 2000. The company intimated - and later outright said - that fluid management, not PolyHeme, appeared responsible for the heart attacks and said Norris would present full study results at next month's meeting.

"We believe his presentation will substantiate our conclusions, as does our extensive experience with PolyHeme in trauma settings," the company said.

But yesterday, Hopkins and Norris said those statements are wrong. Norris said he was not officially the lead investigator of the trial, though he may have unofficially been seen as such because Hopkins enrolled more patients than other trial sites.

Despite his efforts, he said, he didn't get more detailed data from the company until this week, when a packet arrived at his office.

The university demanded a retraction from Northfield. The Evanston, Ill., company complied Monday, saying it "did not mean to imply that Dr. Norris' presentation was designed to substantiate its conclusions about the data."

But Hopkins decided that wasn't enough, leading to yesterday's announcement.

Norris, Hopkins said, "was not given access to full study results from Northfield and does not and cannot substantiate Northfield's claim that PolyHeme was unlikely to have been the cause of 10 heart attacks and two deaths in patients receiving the blood substitute as part of a clinical trial that ended in 2000."

Norris said he did co-author a summary paper - known as an abstract - to be presented at next month's meeting in Spain. But he said he submitted it in early January after getting a data summary from the company, which he expected to be supplemented with full data in time for his presentation.

That isn't unusual, he said, since scientific meetings often set abstract deadlines far in advance.

"As academicians, the currency we deal with is publications," Norris said, referring to the impact publications can have on a career. "Not having the opportunity to publish a study when it was deemed over was something we certainly were not happy about."

So when Northfield expressed an interest in making the presentation, Norris said he was glad to participate.

But he said he began to worry by mid-February, when the company still hadn't responded to his request for all the data. Then came The Wall Street Journal story and calls to Norris' office about PolyHeme from the FDA and Iowa Sen. Charles E. Grassley's office in early March.

Concerned, Norris said he alerted Dr. Daniel E. Ford, Johns Hopkins vice dean for clinical investigation. He said he told Ford that he wouldn't have enough time, even if he got all the data and patient charts immediately, to review the material in time for the presentation.

Neither Ford nor a Northfield spokeswoman could be reached yesterday.

Meanwhile, Northfield has also been defending itself against concerns that it hasn't properly handled enrollment in its clinical trial of PolyHeme among trauma patients. In doing so, it has noted that an independent safety monitoring board has found no reason to discontinue that trial.

Norris, who serves on that monitoring board, confirmed that statement.

Northfield's shares are down 21 percent since Feb. 21, the day before The Wall Street Journal article ran. Yesterday they were up 9 cents, closing at $9.72 on the Nasdaq stock market.

"I think it's always in everybody's best interests to put out results of a trial in a timely fashion," Norris said. "Northfield decided not to do that, and in some ways [it's] now paying the price for that."

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