IVD Technology Magazine
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Originally published May, 1998

IVD Technology News

European BSE talks collapse

Months of negotiations to amend a proposed European Union (EU) ban on materials potentially infected with bovine spongiform encephalopathy (BSE) have apparently ended at an impasse. For IVD manufacturers, that may not be bad news.

The original ban was to take effect on January 1, but implementation was delayed when representatives of the pharmaceutical, cosmetics, and diagnostics industries protested that it would unnecessarily restrict their access to commonly used animal-derived materials. EU officials sought a narrower ban that would not affect IVD uses, but for political reasons were unable to reach a satisfactory compromise.

The EU's failure to come to an agreement leaves in place the wording of the ban as originally proposed, but now without any target date for implementation. If put into effect, this version of the ban could pose a serious threat to the transatlantic trade and manufacture of diagnostics, pharmaceuticals, and cosmetics.

But the broad scope of the proposal may also be its undoing, with many EU officials now suggesting that the proposal be abandoned altogether. To support their position, they cite revised estimates indicating that cases of BSE-related diseases may number in the hundreds rather than the millions originally thought. Moreover, results of a large European study directed by Cornelia Van Duijn of the Erasmus University Medical School (Rotterdam) suggest that eating beef, lamb, veal, cheese, or milk does not increase the average person's risk of contracting Creutzfeldt-Jakob disease (CJD; Lancet, 351: 1081—1085, April 11, 1998).

Signaling the ban proposal's probable repeal, an international commission of veterinary officials recently voted 11 to 4 against passing the proposal.

According to John Place, director general of the European Diagnostics Manufacturers Association, a final decision on the ban will be delayed until December, when it will most likely be struck down. Allowing the law to stand might safeguard human health, Place says, "but it would be a politically and ethically questionable decision to effectively outlaw many drugs and cosmetic products."

Without EU-sanctioned controls on specified BSE-risk materials, member states will have to rely on their own national measures to combat the transmission of mad cow disease. But health-care workers may soon have a new breed of tests to diagnose and limit the spread of BSE and other prion diseases.

The best current diagnostics for prion diseases require postmortem brain examination or cerebrospinal fluid testing. Now, a group of researchers led by Markus Otto, in Göttingen, Germany, believe they have discovered a blood serum protein associated with CJD, which has been thought to arise in humans from contact with BSE-tainted food or products (Brit Med J, 316 (7131):577—582, 1998). Analyzing the blood of 182 patients, the group found that serum levels of a protein they call S100 were elevated in patients suspected of having CJD. The S100 protein is normally found in brain glial cells. Although other neurological conditions can elevate S100 levels, confirmatory tests exist to rule out these other disorders.

Meanwhile, a team of researchers led by Stanley Prusiner and Fred Cohen at the University of California, San Francisco, has reported the preliminary success of a test using transgenic mice to confirm BSE infection in cattle (Proc Nat Acad Sci, pp 14279—14284, December 1997). The team's research into the transmission of prion disease continues the work of Prusiner, who won the Nobel prize for his discovery of prions. He and his colleagues engineered the mice to make them susceptible to BSE, showing symptoms within 200 days of being injected with infected tissue. According to Cohen, the team's development of prion detection methods is ongoing. Industry partnerships are being pursued, he says, but details of the companies involved cannot be disclosed. —G.W.