Å®ÉúСÊÓƵ

SCIENTIFIC advisers to the British government are taking the unusual
step of making public the details of their views on the safety of a new
drug. The drug, bovine somatotropin (BST), boosts artificially the yield
of milk from cattle.

Independent committees usually reveal the details of their considerations
only to the government and the company concerned. The government’s Veterinary
Products Committee (VPC) has adopted this open policy in the run-up to the
first of a series of crucial European meetings this week on BST. It says
it is resisting pressure from industry and advice from former members of
the committee to remain silent.

James Armour, the chairman of the committee and dean of Glasgow University’s
Veterinary Faculty, says the VPC is still not convinced that the drug poses
an acceptably low risk to the health of cattle. Last week, the committee
advised the government to reject an application from Lilly Industries, a
company based in Indianapolis, to market its version of BST in Britain.
The committee also confirmed its earlier advice that ministers should reject
a similar application from Monsanto, the American chemical and biotechnology
company based in St Louis, Missouri.

Armour told New Å®ÉúСÊÓƵ last week that his committee ‘has taken a
bit of stick’ for making public statements. ‘Some people think everything
should be shrouded in secrecy. But we all feel that people should be informed
– without impinging on commercial confidence.’ He says his committee is
unhappy about ‘injection site reactions’, swellings that form after the
drug is administered to the cow.

The swelling is caused by a ‘depot effect’ as the drug must be injected
in sufficient quantities to last until the next injection. ‘Swelling is
usually associated with some level of pain,’ Armour said. He says that in
view of these findings, pharmaceuticals companies may have to reconsider
the ‘carrier’ in which they administer the drug. The committee is also concerned
about an increased level of mastitis, a disease of the udder, found in some
injected herds.

The debate on the hormone is reaching a head in Brussels, as the European
Community approaches the end of a year-long ‘evaluation period’ of the safety,
efficacy and quality of the drug. Europe is also bogged down in the controversial
issue of whether such a drug is needed at all.

British representatives to Europe’s Committee for Veterinary Medicinal
Products (CVMP) will take with them the advice prepared by Armour’s committee
for this week’s meeting. The committee will examine Monsanto’s application
first, then the proposal from Lilly in late November. Europe’s member states
will formulate their own policies based on full guidelines from the CVMP,
expected early next year.

Members of Armour’s committee believe Britain is not alone in its worries
over the animal safety aspects of BST. The US Food and Drugs Administration
published data at the end of August to support its view that the drug presents
no increased risk to consumers. But US authorities have yet to issue a licence.
Alan Taylor, secretary to Britain’s VPC, believes American scientists have
doubts on the animal safety or the quality of the drug. ‘Either way they
are not yet happy with the drug as a whole,’ he says.

Armour confirmed that neither the efficacy of the drug, nor its safety
for humans or the environment, are in doubt in either case. The committee
is concerned, however, about aspects of Monsanto’s production process for
BST.