The long running squabble holding up treatment trials for Creutzfeldt-Jakob disease (CJD) in Britain surfaced again last week when the former chairman of the Prion Trial Steering Committee, Professor Iain Chalmers, said in an article in the Times Higher Education Supplement (5 March, p 1) that a “bitter relationship” between the two leading research institutions was delaying agreement on a national research framework.
The Medical Research Council's Prion Unit at the Institute of Neurology in London has been unable to agree a trial protocol with the CJD Surveillance Unit at Edinburgh University. Both units, however, are now saying they expect to deliver a protocol by Easter.
“There's no good reason why this couldn't have been settled long ago,” Professor Chalmers told the BMJ. “It's been dragging on for two years.” When he last spoke out on the issue, in October 2003, the MRC said it expected a trial framework within a month (BMJ 2003;327: 1069).
Professor Chalmers resigned earlier this year from the chairmanship of the committee set up to agree a national framework to study treatments for Creutzfeldt-Jacob disease and variant CJD. He blames the Department of Health for not pressuring the parties to settle their differences. “I doubt the department will do what's necessary to resolve this unless the public gets involved and demands it,” he said. One cause of the problem was academic jealousy, he added.
The new joint chairman of the Prion Trial Steering Committee, Dr David Armstrong, said there had been concern “from both institutions that their own particular territory not be infringed upon.” But he said there were real difficulties in finding a protocol that was right for patients, most of them arising from the issue of who should own the rights to samples taken from patients.
Dr Armstrong last week met representatives from the CJD Surveillance Unit, the MRC Prion Unit, and the Department of Health, and agreed a further meeting, probably near the end of March. He said he expected a final resolution at that time. “We're thinking of locking them in until they reach agreement.”
Two potential treatments for CJD could be studied. One is the antimalarial quinacrine; the other is pentosan polysulphate, licensed in some countries for bladder inflammation, but in vCJD treatment it would be injected directly into the brain. Three patients have been granted permission by the courts to try pentosan polysulphate. The first to begin treatment, Jonathan Simms, a 19 year old patient with vCJD from Belfast, had stabilised at the last report (BMJ 2003;327: 765), and has surpassed the typical life expectancy of a patient with vCJD by nearly two years.
Although only quinacrine trials are formally being considered by the steering committee, Dr Armstrong said that any national research framework would be flexible enough to include pentosan. “I doubt we'll ever have a placebo controlled trial in this disease,” he said, “since no next of kin is going to let nothing be done for their loved one. A trial comparing two treatments would be likely.”
Professor Colin Blakemore, the MRC's chief executive, said: “It's vital to get the protocol right, so that it can stand up as a procedure for testing any new putative therapy for CJD in the future.”
Figure 1.
Prion fibrils in brain of a cow infected with BSE
Credit: EM UNIT, VLA/SPL