Monsanto’s hopes of winning federal approval to market a dairy growth hormone in Canada received a sharp, and perhaps fatal, setback last week. With Health Canada still studying whether the bovine somatotropin product meets the test of efficacy and safety, as it did in the U.S. in 1994, the government is on the defensive.
Health minister Allan Rock has been forced to vow that there must be no room for doubt before the product is approved.
Given public and scientific skepticism about American test results and public unease about possible hormone residues in milk, that may be an impossible scientific standard to meet.
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Politically, it could be even tougher.
The critics already have covered the entire drug approval system with a blanket of suspicion.
In these highly charged political circumstances, it is difficult to imagine a government screwing up the courage to say the product should be marketed despite the doubts.
Dairy farmers are uneasy at the prospect. Dairy processors are opposed. Consumers are skeptical to indifferent.
And a politically astute citizens’ lobby that includes the National Farmers Union and the Council of Canadians has cast enough doubt on the government’s objectivity that any decision to approve it for market would be challenged.
As an early test of the government’s objective and “science-based” approach to biotechnology products, the BST case has been a fiasco.
To save what little credibility is left, Rock has little choice but to accede to Opposition calls for an investigation of his department’s drug-approval system.
It became inevitable last week during a moment of delicious political theatre on Parliament Hill. It may well have sealed the fate of the BST product.
At a Senate agriculture committee hearing into how the BST review has been conducted inside Health Canada, five scientists appeared to argue that their scientific skepticism has been ignored because of departmental determination to support the corporation.
The scientists appeared only after receiving a letter from Rock assuring them their testimony before senators would not hurt their careers. They said they previously had been put under a gag order not to speak.
As if the image of scientists fighting to tell the truth was not enough, their explosive message was the clincher.
There were tales of secrecy, discipline, stolen papers, locker break-ins, management retribution and alleged harassment.
But most dramatic of all was a gesture at the beginning. Three of the five insisted they take an oath on the bible before answering questions.
Scientist Shiv Chopra said he swore an oath “in the presence of God” to make it impossible for him not to respond truthfully to senators’ questions despite earlier departmental threats of retaliation.
“My question to myself was, what truth am I going to tell,” said the 64-year-old scientist, “the one I know or what the minister is telling me to tell.”
If Rock does not try to clear that air, his political instincts will have failed.
