Levis, December 1998

To whom it may concern,

You will find included the letter that I sent to the Prime Minister Of Canada M. Jean Crétien.

This letter was also sent to M. Allan Rock, M. Preston Manning, and all the leaders of the other parties in Ottawa.

The President of the Canadian Senate also received my letter.

As up to this date ‘’ January 19 1999 I never received any answer to my questions.

As a Canadian, and considering the following articles I must say that in Canada at the moment we are confronted by an ‘’ Health Gate’’.

I must say that they did great reports on the actual situation that prevails in Canada.

Thank for your collaboration

You can use any of the information from my letter to The Prime Minister M. Jean Chretien.

I did not write only for myself, I wrote on behalf of all Canadians including yourself.

The questions that I asked were simple and I am really wondering why I never got an answer.

With the power of your pen, the power of your Newspaper, and with great collaboration, would you please let the Canadian People know what is going on in the Canadian Health Department.

We remain,

Micheline B. Lambert

President

Antonio Lambert

Vice President ( Public and International Communication )

Lévis, 12 November 1998

The Honorable Prime Minister Jean Chrétien

After reading the article published in an Ottawa newspaper, and also in The Globe and Mail, I asked myself many questions.

1: Who, in my country, decides which medication should be put on the Canadian Market?

2: Who decides what the safety standards on these drugs should be?

3: Why did the 6 scientists go to the senate and not to the members of your government (who supposedly represent the people of Canada)?

4: Is it true, that 'certain' scientists were threatened of being sued if they didn't pass drugs from 'certain' companies?

5: Is it true, that they must modify (or bypass) their normal standards under threats from their superiors?

6: Do you know someone who uses (needs) medication approved by Health Canada?

7: Are they comfortable after reading such an article?

8: Me, should I feel safe, since everyday I need to take at least 10 different kinds of drugs to stay alive (cardiac problems)?

9: What do you intend to do to stop such a disgusting scandal (problem)?

10: Are we reliving the 'Blood Problèmes'

11: Is this another Somalia?

12: Are we seeing the same phenomenon as Thalidomide?

13: Why, in 1992, did the Health Minister, ask the companies making breast implants with silicone, to prove the safety of their product, and in 1997, still hadn't received confirmation from these companies?

14: Why is the Health Minister thinking 'money first' and then the Canadian people? Shouldn't it be the opposite?

15: Are the 6 scientist going to be fired the same way as Mr. Pierre Blais Ph.D.. was in 1989 (see La Presse, july 30 1989)? He was 'excused' because he dared to warn the public against breast implants.

I think I have asked enough questions, for now.

I would like to quote my father, sir J. A. Lambert, counsellor to the Queen and the Quebec minister of Work . He liked to say, "The only reason for a government, to be elected to power is for it to take care of it's own children."

Are YOU taking care of your children, with all the health scandals going around?

I congratulate you for your humanitarian gesture you made for the antipersonnel land mines. It's about time though that you started thinking of your own children instead of those of our neighbors.

Mr. Prime Minister, you MUST open a public investigation to find out what's going on at Health Canada.

Who (really) controls Health Canada?

Who (really) governs the people?

Who (really) takes the peoples interest at heart?

So many questions needing straight answers.

Being a Canadian citizen, I deserve and demand answers to all these questions and doubts.

I thank you for taking the time to read my letter, knowing how your time is precious.

Waiting to hear some good news,

Yours sincerely,

Antonio Lambert

If money is the root of all evil, something sinister is stalking Canadian scientists searching for the next miracle drug.

In October, six researchers at Canada's health department, fed up with constant pressure to hurry drug reviews and ignore safety concerns, marched into a Senate hearing and aired Health Canada's considerable dirty laundry.

The scientists said they were pressured by their managers and bribed by chemical giant Monsanto Co. <MTC.N> to approve the company's genetically engineered cow hormone, rBST. St. Louis-based Monsanto said the money was to oversee studies.

Another Health Canada reviewer said she was told she would be sued by drug manufacturer Hoechst Canada, a unit of Germany's Hoechst AG <HOEG.F>, if she continued to delay the approval of the company's growth hormone Revalor-H.

The scientists detailed incidents in which controversial files at the agency had been shredded, stolen and locked up, allegedly to protect the interests of the corporate clients.

Shiv Chopra, a 64-year-old reviewer with 30 years service at the department, said he could remain silent no longer.

"The department is saying all over the place that the client -- and this is in writing -- the client now is the industry and we have to serve the client...We just are unable to deal with it any more," he told the Senate committee.

The revelations came just as the Royal Canadian Mounted Police confirmed it was investigating possible wrongdoing in Health Canada's 1982 approval of the Meme silicone breast implant. The implant was taken off the market in 1991 after it was found to contain a suspected cancer-causing agent.

Allegations that industry influence pervades Canada's health department came as no surprise to Dr. Michele Brill-Edwards, who in 1996 left her senior review job there.

She said industry executives have quick and easy access to cabinet ministers and senior bureaucrats who respond to the industry's "incessant agitation" for drug approvals.

"It creates an untenable tension for a reviewer who has genuine unanswered questions about safety," she said.

Now an Ottawa pediatrician, Brill-Edwards said Canadian scientists want to report the truth but fear reprisals from the powerful corporations who fund Canadian research.

"The (industry) can destroy people if they try," she said.

The race for the next Viagra -- or a cure for AIDS -- has created an industry driven by the promise of profit and fame. But every search for a cure begins with a quest for funding.

To discover insulin in 1921, Frederick Banting approached the University of Toronto and requested lab space, a research assistant, 10 dogs, and eight weeks.

Modern medicine has grown a bit more complex -- and a whole lot more costly. According to the Pharmaceutical Manufacturers Association of Canada, it now takes an average of 10 to 15 years and over C$700 million to develop a new drug.

Canada's cash-strapped Medical Research Council, which provides the bulk of government funding for research, has nowhere near that kind of money. The council's budget dropped 13 percent in four years, to C$235 million in 1996. It has since been replenished to C$267 million a year, but Canada still has the lowest funded research agency in the OECD.

By contrast, the manufacturers association, which represents about 90 percent of drug companies in Canada, said its members will be spending C$1 billion annually by 2000.

"The problem we got in Canada is that there is so little public investment in medical research -- you've got a 4-to-1 ratio of private sector investment compared to public sector investment," pharmaceutical association spokesman Chris Ward said, adding that the ratio in the United States is about 1-to-1.

Health Minister Allan Rock dismissed the suggestion that companies like Monsanto have undue influence by pointing out that rBST has been under review for nine years.

"If someone is exerting pressure, they are not very effective," Rock told the House of Commons.

But the nine-year battle over the synthetic hormone, which received U.S. approval in 1993, may be nearing an end. Stymied by its own reviewers, Health Canada has appointed two outside panels to study rBST safety, a move the National Farmers Union calls "an end run around the science reviewers."

The impartiality of the panels has already come into question. The head of one panel, Dr. Stuart MacLeod, has worked as a consultant for Monsanto's pharmaceutical unit, Searle. His wife worked for Searle for 15 years until last December.

MacLeod said there is no conflict of interest.

"There is nobody in this country who's knowledgeable about these issues who hasn't had some dealings with the pharmaceutical industry," MacLeod said.

And that appears to be the problem. Brill-Edwards said the industry is a giant revolving door of scientists who may need to be in industry's good books to get future funding.

"It's very difficult to separate your work today from what it may be in the future -- so there is a constant concern on the part of the people in drug development that they keep their options open. It's a kind of inherent conflict of interest."

Industry ties go beyond the public sector. Universities, hospitals and private, non profit agencies all work with the drug industry at one level or another.

At Toronto's Hospital for Sick Children, Dr. Nancy Olivieri said generic drug maker Apotex Inc. threatened to sue if she published a study critical of one of the company's drugs. Other researchers came to Olivieri's defense, but the hospital administration did not -- prompting charges that it was trying to protect its relationship with Apotex.

The Apotex Foundation is one of the 10 largest philanthropic research foundations in Canada.

"We need to find out about the relationship between Apotex and this hospital... (and) why Dr. Olivieri and others have been consciously and persistently harassed inside the hospital -- simply for telling the truth," three of the hospital's doctors said in a statement.

Henry Dinsdale, president of the National Council on Ethics in Human Research, said there is no easy way to end the constant conflict between industry and scientific motivations.

"The resources of industry are essential to really be able to develop a product so it can be brought to market. So it's simply an area of tension that needs constant vigilance."

But some researchers fear vigilance may scare industry money away. International standards are being loosened, not tightened, as countries compete for funding in what Brill-Edwards calls a "race for the ethical bottom."

"Researchers do make this argument, that if we have safety standards that are too rigorous -- I call them integrity standards -- we just won't get money for research," she said.

"And that's perhaps where the ethics of this whole thing are laid bare. Are they really telling us that they will do anything to get research money?"

($1=$1.53 Canadian)

18:00 11-06-98

As a scientist employed by the federal health protection branch, Mr. Blais wanted to ban a popular breast implant because he had evidence that its foam coating could make women sick.

His superiors disagreed. They tried to bully him into backing off and when that failed, they fired him. Mr. Blais challenged his dismissal and won, but he decided to leave anyway.

It was eight years ago, but time has not eased the anger or fear in his voice as he compares his former workplace to East Germany under the Communists, a secretive place where those who speak out are intimidated and big business really calls the shots.

"I left for fear I would be the person who would have been forced to approve the next thalidomide," he said in a recent interview. "Imagine the nightmare."

He left in 1990. The following year, the manufacturer took the product off the market. It was the notorious Meme breast implant.

Today, Mr. Blais is still in Ottawa, working as a consultant and watching with keen interest as his old workplace is put under the microscope.

Clearly something has gone terribly awry in the complex on the Ottawa River that houses the health protection branch. Its 1,360 scientists and support staff are the biomedical guardians of the nation. Their job is to protect Canadians from bad drugs, contaminated food, tainted blood and unsafe baby cribs and other consumer products.

Now the question is, can they still do it?

In recent weeks, six of the branch's scientists have complained that their superiors tried to force them to approve the genetically engineered bovine growth hormone despite their concerns that it isn't safe. Already in use in >the United States, the hormone increases milk production in cows, but critics fear that such milk may not be safe for children to drink. The scientists' testimony before a Senate committee was like a scene from the conspiratorial television show The X-Files.

Margaret Haydon, her voice quavering, told how her files had been broken into and how she was taken off the case after she recommended that the drug not be approved.

She said Monsanto, its manufacturer, had offered Health Department officials research money they interpreted as a bribe, an allegation the company denies.

The senators were stunned by the accusations, but Mr. Blais wasn't surprised.

"It isn't an isolated incident, but this is part of a pattern," he said in an interview in his Ottawa home. "But over the years they have only gotten more sophisticated at concealing what is going on."

The RCMP believe that the truth is out there, and it has launched three investigations involving Health Canada.

They are looking into the tainted-blood tragedy of the 1980s, when thousands of Canadians were infected with the AIDS virus and hepatitis C >while the health protection branch was responsible for regulating the blood system.

The police are also investigating the destruction of key documents by Health Canada officials. A damning report from the federal Information Commissioner found that officials destroyed what might have been crucial evidence because of pressure from the Red Cross, which feared victims would be able to use the documents in lawsuits.

The third investigation is an attempt to determine whether Health Canada officials approved the Meme breast implant despite knowing that it wasn't safe.

The Public Service Staff Relations Board is hearing a grievance from the six scientists over bovine growth hormone. Their complaint seems to mirror earlier accusations levelled against the department and the day-to-day concerns of other scientists who work there.

They say pharmaceutical manufacturers have far too much influence in the drug approval process and scientists often feel that their careers are threatened if they stand in the way of a drug they don't believe is safe.

"The department is saying all over the place that the client -- and this is in writing -- the client is now the industry and we have to serve the client. Although we have to ensure that safety is there, our situation has changed," researcher Shiv Chopra told the Senate committee.

Michelle Brill-Edwards, a medical doctor who quit the branch in 1996, said the culture of the department is such that scientists who raise questions about new drugs are deemed to be troublemakers, while those who quietly approve them are promoted. She left, charging that the branch was putting the interests of the pharmaceutical companies ahead of public safety, and went public with her accusations.

Mr. Blais said he was frequently called in for questioning by his superiors in a manner that made him feel like a criminal for wanting to protect public safety. Although reluctant to give specifics because of the RCMP investigation, he said he also was pressured by industry.

"On one occasion they called and said, 'Don't you know we are millionaires? Why are you making life so difficult for us?' " Mr. Blais said.

The scientists also say cuts to the branch's budget have denied them the tools they need to challenge manufacturers if a product seems unsafe.

In 1993-94, the budget was $237-million; in 1999-2000, it will be $118-million. Laboratories have been closed or scaled back and staff reassigned.

"I am miserable," one researcher said, speaking on condition she not be identified, "because I am responsible for deciding if a product is safe and I can't do my own research, or even access the research of others, to find out. It is a terrible feeling, knowing you are responsible but that you can't do your job."

The scientists also complain that managers without scientific experience regularly overrule their decisions. The result has been strained and at times poisonous employee-management relations.

"The frustrations in the workplace that detract from job satisfaction generally involve the lack of support, inaccessibility, lack of technical knowledge and the inability to admit mistakes," a 1994 report on morale reads. "The decision-making process was thought to be untimely, inconsistent, unfair and, at times, politically based."

A culture of intense secrecy makes it difficult for scientists to do their jobs and for Canadians to know whether they can have faith in the system, the six scientists say.

They were ordered not to speak out publicly. They testified before the Senate committee only after receiving written assurances from Health Minister Allan Rock that they would not be punished.

Mr. Blais said the problems began in the mid-1980s, when the Progressive Conservatives took office in Ottawa. In an effort to cut the backlog of drugs seeking approval, the government contracted out safety reviews to private consultants, some of whom also work for drug manufacturers.

The Liberals took power in 1993 determined to cut the deficit, which exacerbated the problems.

More of the costs have been transferred to the pharmaceutical industry, which now pays for about 70 per cent of its product reviews. Critics say that gives it far too much control over how the department works, an allegation that Health Canada says is unfounded.

Mr. Rock became Health Minister last summer, eager to avoid controversy over a branch that posed problems for his predecessor. He froze the budget cutting, set up an advisory board of independent scientists to help him make decisions and launched a three-year "transition process" to consult Canadians on the future of the branch.

But the furor over bovine growth hormone -- including accusations that managers shredded key documents -- blew up just as the first stage of public consultations were ending.

Obviously frustrated, Mr. Rock has insisted repeatedly that the hormone will not be approved until it is proved to be safe, and his deputy minister, David Dodge, has attempted to reassure the public.

"The job of the department, and we must be extraordinarily clear about it, is to protect the health and safety of Canadians . . .," he told the Senate committee.

Mr. Dodge, a former deputy finance minister, told the committee that the branch suffers the pressures of competing interests.

On one hand, when new drugs -- for example ones used to fight AIDS – are available elsewhere but not in Canada, the public clamours to speed up their approval. On the other hand, approving unsafe drugs can be deadly.

Mr. Dodge added that the secrecy is necessary because drug companies invest millions in research and do not want it to fall into a competitor's hands. If that were to happen, they will simply ignore the relatively small Canadian market.

However, there has to be a way to "shine light" on branch activities without giving away secrets, Mr. Dodge said. The options would include using the Internet or allowing consumer representation in the approval process.

As for social and moral questions such as those raised by bovine-growth hormone, he said the answer may be to give Parliament a greater role in the decision making.

One major obstacle to the "transition" process for the branch is the low morale among the staff and the deep suspicion some researchers have of their managers and political masters. There is a fear that the proposed reform is actually the final step in the deregulation of health protection begun by the Conservatives.

For example, the government has been accused by the Canadian Health Coalition (made up trade unions and other groups with an interest in the branch) of wanting to rewrite the Food and Drug Act to remove the government's criminal liability should something go wrong. It's an allegation that Ian Shugart, who is in charge of revamping the branch, has denied many times.

And what does Pierre Blais make of it all?

He remains convinced that any change will be cosmetic. "The biggest danger of the process is that it will lull the general public into believing they are protected."

A sampling of health protection branch controversies:

The big current item, this drug has been under review for more than eight years. The Health Minister says it won't be approved until he is satisfied it is safe. Documents show that senior branch officials have already told the manufacturer that it poses no threat.

This week, the Health Department issued a warning about toxin dangers in soft plastic toys that youngsters might put in their mouths. Environmentalists want the warning also applied to plastic raincoats, backpacks and dozens of other toys. An earlier study found no risk associated with any such products.

Allowed on the Canadian market without a safety review, it prompted branch scientist Pierre Blais to seek a ban in 1990 after finding that it was covered with a foam used in carpets and upholstery. A year later, the manufacturer withdrew the product after the U.S. government determined that the cover leaked a potential carcinogen.

Tainted blood This fall, Health Minister Allan Rock announced the spending of $125-million over five years to implement the recommendations of the Krever inquiry, which was highly critical of the branch's handling of the blood supply in the 1980s, when thousands of Canadians were infected with hepatitis C and the AIDS virus.

Dr. Michelle Brill-Edwards resigned from the department in part over the approval of this migraine drug, later found potentially dangerous to people with heart conditions.

GenetiX Update

December/ January 1999 Number 11

There is now no doubt about the tremendous impact that campaigns across the UK against genetically manipulated foods are having on Monsanto and major food retailers.

The massive propaganda campaign run by Monsanto over the summer has completely failed. A report leaked to Greenpeace, written for Monsanto by a former polling advisor to Clinton, Blair and Nelson Mandela, reveals "an on-going collapse of public support for biotechnology and GM foods. At each point in this project, we keep thinking that we have reached the low point and that public thinking will stabilise, but we apparently have not reached that point." Retailers interviewed in the report suggest that GM food could "turn out like irradiation. Which is, you don't do it." Others talk of a "fifty-fifty" chance of "losing to the pressure groups".

Such comments reflect the amazing amount of work that has gone into the campaign against GE and provides inspiration for it to continue to grow. More and more people are opposing the activities of biotech giants like Monsanto and the complicity of major retailers and food producers. The public perceived the biotechnology companies as " willing to risk great human danger in order to make profits." The message for Monsanto is clear: stop genetic manipulation of food.

What is also depressingly clear from this report is the acceptance by politicians of the "benefits" of genetic manipulation, "70% of the MPs (interviewed) reacted positively to GM foods." Just how out of touch are these people? Even a moratorium " gets little support among the MPs and civil servants." For a copy of the Monsanto leak phone 0800 269065 or visit the Greenpeace website: http:/www.greenpeace.org.uk/monsanto>http:/www.greenpeace.org.uk/monsanto

From the Organic Farmers Marketing Association

Communication/Telecommunication Committee Co-chairs: Cecilia Bowman,

cvof@iquest.net, Eric Kindberg, erorganic@aol.com

Website: www.iquest.net/ofma/

December 4, 1998

After due consideration the Board of Directors of the Organic Farmers Marketing Association has determined the following:

The Organic Farmers Marketing Association calls for an complete prohibition on the use of Genetically Engineered plants, seeds, microbials, animals and derivatives from GE products in certified organic farm food and fiber production.

(13 December 1998)

A KEY government report on the effects of growing genetically modified crops has been suppressed because of its controversial warning of serious environmental risks. It says there are serious dangers to Britain's hedgerows, birds and indigenous plants from growing GM crops on a

commercial scale.

The report, commissioned by ministers to assess the potential effects of cultivating GM food in Britain, concludes that there are insufficient safeguards to stop the creation of hybrid multi-resistant plants.

It lists a series of "gaps" in the UK's regulatory framework, leaving Britain's wildlife at serious risk of damage from genetically modified plants and other intensive farming methods.

The news comes as the Health and Safety Executive, responsible for monitoring GM crop trials, has revealed that in the six months between April and October this year more than one in 10 of the 49 sites inspected during that period had been breaking the regulations governing trials. This week it is expected to prosecute Monsanto for such breaches - the first ever criminal case of its kind.

The study, written by civil servants after widespread consultation with government advisers, also warns that the commercial growth of GM crops could lead to more pesticides being sprayed on Britain's fields.

_________________________________________________________

Richard Wolfson, PhD

Consumer Right to Know Campaign,

for Mandatory Labelling and Long-term

Testing of all Genetically Engineered Foods,

500 Wilbrod Street

Ottawa, ON Canada K1N 6N2

tel. 613-565-8517 fax. 613-565-1596

email: rwolfson@concentric.net

Micheline B. Lambert Présidente

Info Implants Mammaires Inc.

E-mail : delphine1939@videotron.ca

URL: http://www.info-implants.com