Whistleblowers at Health
Canada Protect Food Safety
"Is it safe or isn't it?" "Well it must be safe if the government approved it." Canadians want to believe that if a product isn't safe, it won't be on our shelves. Recently two Health Canada scientists were found not guilty of a "breach of loyalty" when they blew the whistle on pressure tactics within Health Canada's Bureau of Veterinary Drugs (BVD). Their case focused public attention on how safe our food supply really is - or isn't.
In 1998, Dr. Shiv Chopra of the Human Health Division, and Dr. Margaret Hayden in the Animal Health Division, were evaluating the bovine growth hormone rBST. The product was controversial. RBST producers claimed it increased milk production with no negative effects on humans or animals. But Hayden and Chopra both concluded that it was not safe. They recommended that the product not be approved. Supervisors in the department pressured them to approve the drug anyway.
This was not a new problem. Drs. Chopra and Hayden and other scientists in the department had become seriously concerned with the drug approval process generally. In particular they were concerned about two categories of drugs, growth hormones for meat and milk stimulation and antibiotics. In December1997 they sent a letter through their union to Prime Minister Chretien stating "We believe the regulatory intent of this Act (Food and Drugs Act and Regulations) is being compromised to the point of placing the health of Canadians in jeopardy. Our members are being pressed by management to ignore rigorous professional standards of practice, thereby creating unacceptable and unnecessary risks in the drug assessment process...Health Canada plays an integral part in ensuring Canadians do not face disasters such as BSE ("mad cow disease"). We cannot afford to play "Russian Roulette" with the legislation that governs the inspection of food and drugs in this country."
In June of 1998, when neither the department or the Prime Minister had responded to their concerns, Chopra and Hayden were invited to speak on Canada AM about rBST which was by then the center of a public controversy. They publically raised their concerns about the product, and the pressure tactics within the department. As a result, they were officially reprimanded and told that they could not speak in public without permission from the department for two years.
Meanwhile, the Standing Senate Committee on Agriculture and Forestry was looking into rBST. They supoenaed Chopra and Hayden, who were assured that testifying to a Senate committee would not open them to further reprisals at work. In their evidence before the Senate committee, Chopra and Hayden repeated accounts of the pressure tactics in the department. Hayden also revealed that her research files on rBST had been stolen from a locked file cabinet, and that she had been present at a meeting where Montsanto, the makers of rBST, had offered Health Canada one million dollars if the drug was approved.
Shortly after, Chopra was suspended for 5 days. His supervisor claimed it was for criticizing Health Canada for racism in a public forum. A Senate investigation heard evidence from seven scientists in the department that this action appeared to be in retaliation for his testimony.
The two scientists appealed both the gag order and the suspension. They recently won both cases. Along the way, the process has revealed a pattern of ongoing problems in the department. The National Farmers's Union was one of the organizations which intervened in the Federal Court case which appealed the gag order and reprimand. The NFU's regional coordinator for Ontario, Peter Dowling stated "Through our years of involvement in the milk hormone issue, the NFU has seen the seamy side of the whole regulatory process...If this situation continues, the whole food system will suffer." The NFU believes "farmers have a direct interest in ensuring the integrity, transparency, and accountability of Health Canada's food regulatory processes. The market for the food we produce is heavily dependent on consumer trust in its purity and safety. The precautionary principle, embodied in the Food and Drug Act, is intended to protect that trust and Health Canada must implement that principle."
The Sierra Club, the Council of Canadians and the Canadian Health Coalition, all of which are non-profit public interest groups, also intervened in the case. They pointed out that freedom of expression must also protect the right of the public to receive information and ideas which make it possible to form opinions, make decisions and participate in public dialogue on an informed basis. They argued that disciplining public servants in situations like this also limits the ability of non-profit organizations to protect public health and the environment, and safeguard the integrity of government procsses.
The Federal Court decision is a clear victory for public servants and public safety. Justice Tremblay-Lamer wrote, "The scientists were justified in going to the media...They should not have been reprimanded/restricted for disclosing information relating to the troubled drug approval process within the BVD..." She also ruled "Where a matter is of legitimate public concern requiring a public debate, the duty of loyalty cannot be absolute to the extent of preventing public disclosure by a government official. The common law duty of loyalty does not impose unquestioning silence."
Behind these disciplinary actions is a major shift in the Health Protection Branch's role and the standards it applies to determine food safety. Client satisfaction is the new guideline. But departmental memos instruct scientists that their clients are not the public, but food and drug manufacturers looking for product approval. There is also a switch from a precautionary approach to one of "risk management" where food-safety regulators are supposed to "manage the damage" (to human health and the environment) instead of preventing harm from happening.
Health Canada is having trouble keeping these issues behind closed doors. In April 1999 the European Union audited Canada's meat supply and revealed "serious deficiencies". It documented widespread use of cancer causing hormones, antibiotics, endocrine disrupters and other hormonally active substances, all of which are banned in Europe. Canada promised that it could provide the European market (but not Canadians) with chemical free beef. Health Canada officials tried to write the audit off as a "trade dispute" but these were the same substances that department scientists had recommended against approving.
The Carbadox controversy is a recent example of what our new "risk management" policy means in practice. Carbadox is a growth hormone for pigs which has been in use for 20 years. Its safety has been questioned by scientists for years. Recently all five scientists in the Human Safety Division of Health Canada, all long term employees, called for an immediate moratorium on the product. Studies show that Carbadox is both carcinogenic and genotoxic. In laboratory studies, all the mice studied died within 4 months. Small barbeque pigs are slaughtered without a withdrawal period from the drug. Residue from Carbadox enters the environment through pig feces. In response to the scientists' call for a ban, Health Canada managers asked them to prepare a memo on "the safe use of Carbadox. " The scientists refused, saying there was no safe way to use the product. But the scientists do not have the authority to approve or ban a substance. That decision is up to the managers, who often have no relevant scientific background, so Carbadox is still in use.
The latest debate is around Baytril (endoflaxin), a poultry antibiotic. It's an important antibiotic for humans, but since its use in poultry has become common the germs it is used to treat are becoming resistant. One drug evaluator in the BVD was threatened with disciplinary action when he insisted that Bayer, the drug's manufacturer, provide more data on human safety. Important files on Baytril went missing in 1999 and 2000.
Now seven of the BVD scientists, including Chopra, are asking their union to demand a Senate investigation into the way the Bureau regulates drugs used to treat animals eaten as food and whether or not the department is hiring and promoting unqualified people. Chopra said the scientists feel they have exausted all other channels to get these issues addressed. "We are saying that there are two classes of drugs, hormones and antibiotics (that) should not be in our food supply... Now we're ready to take that concern to a higher level" he said.
In February, Chopra and Hayden were presented with the Canadian Whistleblowers' Award for Outstanding Committment to the Public Good at a forum on Science in the Public Good. Consumer advocate Ralph Nader, a speaker at the forum commented, "I have seen many whistleblowers before. Usually they speak about how difficult things were. But this is the first time I have met whistleblowers who come out roaring about what they are going to do next."
Thankfully Canada has these roaring public servants who, with the protection of the courts, are playing a critical role in defending public health.
For more information on food safety visit the website of the Canadian Health Coalition, www.healthcoalition.ca. On the CPAC cable channel look for the Public Forum on Whistleblowing, from October 4, 2000.