GM drug critics sacked by Health Canada (16/7/2004)

"There is war at Health Canada... The battle erupted in 1998 with the evaluation of rBGH (genetically engineered bovine growth hormone)" - Dr Richard Wilson writing in the Canadian Journal of Health and Nutrition (item 3)

"This is retribution for having spoken out about what's going on at Health Canada and the concerns they have around the safety of drugs for veterinary use" - Steve Hindle, president of the Professional Institute of the Public Service of Canada

"This is really serious because Margaret and Shiv, they were kind of the last few scientists at Health Canada who were really looking out for health safety" - Michael McBane of the Canadian Health Coalition. (item 1)

1.Health Canada fires 3 scientists
3.Conspiracy to Silence - Scientists Muzzled at Health Canada

1.Health Canada fires 3 scientists
Staffers often criticized policies
Agency denies statements at issue
The Star, 15 July 2004

OTTAWA - Three senior Health Canada scientists known for questioning the department's commitment to veterinary drug safety have been fired.

However, Health Canada says the reason for the termination of Shiv Chopra, Margaret Haydon and Gerard Lambert has nothing to do with their outspokenness.

"It is not because of anything they may have said publicly," said Ryan Baker, spokesperson for Health Canada.

He did not outline the reasons for their dismissals, saying that the information is personal and protected by the federal Privacy Act.

Steve Hindle, president of the Professional Institute of the Public Service of Canada, says Health Canada's public statement belies the truth.

"This is retribution for having spoken out about what's going on at Health Canada and the concerns they have around the safety of drugs for veterinary use," he said.

The firing is the latest in a series of conflicts between Health Canada and the scientists who worked in the veterinary drugs directorate.

Last year a memo revealed that they warned their superiors that the department's strategy to fight BSE was inadequate.

In 2001, Chopra and Haydon said the department was leaning on them to approve a drug that would be used in chickens and cows that could lead to antibiotic resistance in people.

Health Canada officials denied it.

That year, Chopra also accused Health Canada of media hype by overstating the danger to Canadians posed by bio-terrorism agents such as anthrax.

In 1998, Haydon and Chopra spoke out publicly about being pushed to approve drugs without enough assurances of safety from manufacturers.

They were reprimanded by the department, but the Federal Court ruled in the scientists' favour, saying their outcry was in the public interest.

Michael McBane of the Canadian Health Coalition, a public-interest watchdog group, said the firings will send shivers through the public service.

"This is really serious because Margaret and Shiv, they were kind of the last few scientists at Health Canada who were really looking out for health safety.

"Margaret in particular was very involved in recent years around the BSE issue and was speaking out in terms of the real risks and dangers we were facing and she was disciplined for that as well," McBane said.

"It will send a real serious signal throughout the public service that there's no such thing as protecting the public interest. You serve the minister and the minister in turn is serving industry," he added.

Legislation to protect whistle-blowers was introduced this year as part of Prime Minister Paul Martin's pledge to clean up government in light of the sponsorship scandal.

However, Hindle said that in fact, the legislation does not adequately spell out the basis on which public servants are protected.

"The legislation didn't really say people had the right to speak publicly about issues that caused some concern, concerns about health and safety of Canadians," he said.

Hindle's organization, which has represented Chopra, Haydon and Lambert in the past, will do so again, he said.

"We'll have to establish the facts, and part of the facts will be that these people have a reputation as whistle-blowers, they've been in the public eye, and the managers in the department have tried to impose discipline on them in the past."

That discipline included verbal and written reprimands and attempts to suspend them (Chopra was suspended for five days in 2002).

Hindle said the scientists will have to file a grievance with Health Canada. The institute can then make the case that the discipline imposed was too severe and that their jobs should be reinstated, he said.

The Public Service Staff Relations Board will decide.

If the scientists are not satisfied, they could pursue the case in Federal Court, he said.

by: Wolfson, Richard, Ph.D.

Prior to 1980, Bovine Growth Hormone (BGH) could only be obtained from cows, but with the development of genetic engineering, scientists were able to genetically engineer bacteria that were able to produce BGH in the laboratory. Even in the mid-eighties, scientists who were developing BGH
were very concerned and said we should have long-term testing before we start using this in cows. When we inject a hormone into an animal or a human, it affects other hormones and it can have a whole cascade of effects which no one really knows. In Europe, hormones are not permitted to be used in cows; so Monsanto decided to change the name of BGH to bovine somatotropin (rBST) which was created to avoid using the word 'hormone'.

In 1988, about four different companies applied in Canada for the approval of bovine growth hormone. One of the scientists, Dr. Shiv Chopra in the human safety division of the Bureau of Veterinary Drugs, requested more information on the long-term effects on human health, particularly on the effect on the immune system and on birth defects, but no long-term studies had been conducted. The only research that was done, was a 90-day study on 30 rats. And even that study was not available to the scientists. So Dr. Chopra submitted a request for more research to ensure that it was safe, and the main effect of his request was that he was taken off the BGH review, and all of the other scientists in the Bureau of Veterinary Drugs were also taken off the review of BGH. It seems that industry pressured Health Canada and the only people who were allowed to do the review of BGH were the upper level management. The fellow, Monseignon, the chief of the Human Safety Division approved it, going against the advice of his own scientists, even though the scientists said it wasn't safe for humans because the safety tests weren't done to prove it which is a very scary thing - that he could veto his own scientists. That happened around 1990.

Health Canada based their approval solely on an abstract of a study published in Science magazine by two American scientists who worked for Monsanto. This was the 90-day study of 30 rats. During the whole time period, from 1994 to 1998, the scientists at Health Canada couldn't even get a look at it because the complete study was kept locked up and kept secret. By law, the scientists in Health Canada are supposed to study the research before the drug is approved.

In 1993, when BGH was approved in the U.S. it was approved on the basis of the same limited information in this journal abstract. Upper management level scientists at Monsanto claim that since BGH is a protein, it gets digested and broken down so there won't be any physiological problems. However, within the last year, the scientists at Health Canada were able to obtain the whole study. Research on the animals showed that BGH does pass through the gut, the animals had increased antibody levels, and at the same time there was damage to various organs such as cysts in the thyroid and inflammation of the prostate and other glands.

There are two levels of approval. First there is approval for human safety and then there is approval for animal safety. After BGH was approved in the Human Safety Division in Canada, against the advice of the scientists who got vetoed by their boss, it was passed onto the Animal Safety Division. In the Animal Safety Division it wound up in the hands of another scientist, Margaret Hayden, and the people who passed it along to her didn't realize she had a conscience. So she started looking at the results of the research that was given to her (industry does the research, and they pass it along to Health Canada). She found problems such as mastitis or inflammation of the udder, joint problems, deformed offspring, and a decrease in lifespan of up to two years. So Dr. Margaret Hayden recommended it not be approved. What do you think happened to Dr. Margaret Hayden, after she made this recommendation? She got dropped. She was never allowed to study BGH again.

Margaret Hayden was one of the scientists who were at a meeting with Monsanto officials when they offered Health Canada one to two million dollars to approve BGH without any further studies. Fifth Estate, Canada AM, and several other TV stations have confirmed this by talking to other people present at the meeting. Len Ritter, the Director of the Bureau of Veterinary Drugs tried to pressure Margaret Hayden to approve BGH conditionally, and subsequently keep records of the effects of the hormone on the cows and the humans. Margaret responded that it's illegal to approve a drug, and allow it on the market before it is shown to be safe. Then what happened to Margaret was very scary, to say the least. A few weeks later, Margaret came in Monday morning and realized someone had stolen all her records on Bovine Growth Hormone, research showing that it producedlameness in animals and increased mastitis, as well as the notes she had taken at the meetings when Monsanto offered one to two million dollars to Health Canada.

Back in 1996, scientists in the Bureau of Veterinary Drugs filed a grievance that they were being pressured to approve drugs against their professionaljudgement, that they are being coerced and threatened. These are scientists who are just trying to protect our health. Another hormone, Revlor H, is injected into cattle to get them to produce more meat. Margaret Hayden looked at the research on Revlor H and found enlarged ovaries, uterus and prostate, and shrunken thymus glands, which were very extreme warning signals. She tried to stop it and her boss, again, vetoed her and approved it anyhow. Another scientist agreed that it shouldn't be approved, and Don Landry, the Head of the Bureau of Veterinary Drugs said, "So what. They are just going to be slaughtered." The scientist said, "What do you mean? They are going to be eaten." There is some extreme financial pressure being exerted by industry on Health Canada.

Early this year, the Canadian Senate Agriculture Committee was conducting its own evaluation of BGH, and when they heard Margaret Hayden's reports of bribery and of stolen documents, they were completely amazed. They didn't believe they were in Canada. When the Senate Agriculture Committee gave its interim report on BGH, one of the main recommendations was that there should be a very deep investigation of the relationship between Health Canada management and industry, because they are just too closely intertwined. Industry gives Health Canada money to do research. As a result, Health Canada looks on industry as its client and wants to keep its client happy, so it wants to process its requests for drug approvals very quickly. And that is basically what is going on. Finally, at the beginning of 1999, Health Canada decided that it couldn't push BGH through, but they still wouldn't admit that there were safety problems for humans, because they had already announced back in 1990 that it was safe.

But that's not really the end of the story, because it is still being used in the U.S. The Consumer Union, Michael Hanson, and various public interests groups want an investigation into the approval process. It seems their approval process is what they call a 'revolving door policy'. Margaret Miller who did much of the research on BGH at Monsanto, was then hired by the Food and Drug Administration (FDA) of the US government, and then she ended up approving her own research on BGH. So it seems the whole approval process and the relationship between industry (particularly Monsanto) and government health departments both in Canada and in the U.S. are slimy.

3.Conspiracy to Silence
Scientists Muzzled at Health Canada
by Richard Wolfson, Ph.D.

Reprinted with permission from the March 2001 issue of Alive: Canadian Journal of Health and Nutrition

There is war at Health Canada. On one side of the battlefield stands Dr Shiv Chopra and other drug evaluators who firmly refuse to approve drugs of questionable safety. On the other side stands the Drug Directorate management - influenced by pharmaceutical companies who wish to facilitate a fast-track of drugs to market.

The battle erupted in 1998 with the evaluation of rBGH (genetically engineered bovine growth hormone). When rBGH is injected into dairy cattle, cows produce more milk. Chopra and other scientists uncovered research showing rBGH causes safety problems for animals and humans. Sparks flew when they would not approve the drug and the Senate Standing Committee on Agriculture and Forestry investigated the resulting commotion. The Committee called the scientists to testify. After hearing about the dangers of rBGH, the senators recommended that the drug not be approved - a decision Health Canada eventually agreed to.

The Health Canada scientists also told the Committee about other drugs of questionable safety that had been approved against their advice including growth hormones for animals that had been allowed even though the drugs were known to produce deformities in animals and were linked t cancer!

An Attempt to Silence

Health Canada officials were frantic! Corruption in its drug approval process was exposed. How could it silence the dissenting scientists?

On July 23, 1999, two months after Chopra spoke before the Senate his supervisor, Dr André Lachance, suspended him for five days without pay. But at the end of the same year another Senate committee began investigating whether the suspension was retaliation against Chopra for testifying before the Senate. Such retaliation is against the law. This investigation was stalled due to various events, including the disappearance of Dr Lachance, Director of the Bureau of Veterinary Drugs - a key witness.

Shortly before Lachance was to testify, his lawyer sent a letter stating that he was on stress leave and couldn't appear for questioning!

At about the same time, the Federal Court of Canada investigated and removed a gag order that Health Canada imposed on Chopra in 1998 forbidding him from speaking to the press or in public about concerns regarding the health of Canadians being risked. The court ruled Chopra was justified in speaking to the public because he had first exhausted all possible government channels for voicing his very serious concerns.

Grievance Hearings

The Senate's investigation of the five-day suspension was stalled. In the meantime, Chopra filed a grievance with the Public Service Staff Relations Board (PSSRB) of Canada, claiming he was unfairly suspended. After various delays, including another failed attempt to get Lachance to testify, the PSSRB heard the grievance from November 28 to December 1, 2000.

Government officials said that Chopra was suspended because he spoke critically of Health Canada in March of the previous year at a Heritage Canada meeting. This argument made little sense since Chopra had been making these same allegations for many years, criticizing Health Canada's record on racism. In fact Chopra had actually won a landmark case on the matter in the Canadian Human Rights Tribunal.

The Plot Thickens

The grievance hearings took an amazing twist with the testimony of Hugh Hards, Senior Human Resources Advisor at Health Canada, who unwittingly proved that there was a conspiracy on behalf of senior management to muzzle Chopra.

Hards testified that he had attended the disciplinary meeting with Chopra purely as a witness to take notes. New documents surfaced that contradicted several points from his testimony. In fact, these documents showed that Hards had actually recommended Chopra's disciplinary action. More damning evidence showed that Hards had even compiled the questions asked at the meeting. Copies of e-mails and briefing notes from July 23 showed that after the meeting, he wrote the report that recommended disciplinary action. Hards, a member of senior management, who first said he had little role in the disciplinary meeting or the suspension, in fact, played a key role in both!

Under cross-examination, he had no choice but to admit that his testimony contradicted the new evidence. He also admitted to altering his notes from the July meeting, after obtaining input from Lachance and another colleague from the Human Resources Branch (who was not even at the disciplinary hearing). Hards' testimony conveniently hid facts that proved senior management conspired against Chopra.

This case illustrates enormous underlying corruption at Health Canada, with senior management dancing to the tune of industry pressure and coercion. Fortunately, Dr Chopra and other government whistleblowers are battling against these pressures in order to safeguard the safety and rights of Canadians.

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