Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 27 - Evidence for the morning sitting
OTTAWA, Monday, December 7, 1998
The Standing Senate Committee on Agriculture and Forestry met this day at 9:06 a.m. to study the present state and future of agriculture in Canada (recombinant bovine growth hormone, rBST, and its effects on the human and animal health safety aspects).
Senator Leonard J. Gustafson (Chairman) in the Chair.
[English]
The Chairman: Honourable senators, we will call the agriculture committee to order. This morning we are meeting again on the rBST and its effects on human and animal safety in regard to the injection of the hormone into dairy cattle. We have a very full day today and we will try and be as disciplined as we possibly can to give all the witnesses a fair chance to give evidence and also for questions.
We will begin with witnesses from the Vermont Public Interest Research Group and I will ask you to introduce yourself. Welcome to Canada.
Mr. Anthony Pollina, Senior Policy Advisor, Vermont Public Interest Research Group: Honourable senators, I appreciate the time you are taking to listen to what we have to say this morning. You are dealing with an extremely important issue and one that we have had the opportunity to learn from over the last 10 years or so.
The Vermont Public Interest Research Group is the State of Vermont's largest consumer and environmental organization. In a previous incarnation, I was advisor to Vermont's representative to the United States Congress, Bernard Sanders. Bernard Sanders serves on the subcommittee of the U.S. Congress that oversees the Food and Drug Administration.
During my time with the congressman, I was able to meet with the FDA many times, including the administrator of the Food and Drug Administration at the time. I worked closely with both the inspector general of the agency of health and human services and the congressional general accounting office which is the research arm of the U.S. Congress to look at various aspects of the FDA approval of Monsanto's rBGH.
Prior to working for the congressman, I was also the executive director of an organization called Rural Vermont, which is a farm and rural advocacy organization.
In these positions, I have had the opportunity, if you would call it that, to be actively involved in monitoring the FDA review of rBGH since about 1988.
The FDA approval process that I witnessed has been characterized by misinformation, by cover-up, by the skewing of data, by violation of the approval process rules at the FDA and conflicts of interest between the FDA and Monsanto.
Neither the FDA nor Monsanto have been completely honest with the citizens or the policy-makers. They have violated the public trust, they have weakened our faith in their ability to regulate the product and to protect the public health and interests of consumers and farmers.
I have seen Monsanto act in what I would call a pattern of misinformation. I have also seen the FDA be willing to accept Monsanto's misinformation as the truth.
Given our experience in the U.S. I wish to begin by urging you to continue to probe and demand the truth and not make the same mistakes that were made by the U.S. FDA.
While Monsanto will argue that the rBGH is the most studied drug ever, the truth is that all the research on the drug has been done by the Monsanto company or by researchers working under contract to Monsanto. Monsanto has attempted and to a large extent succeeded in controlling the flow of information concerning rBGH.
I will now attempt to briefly summarize some of the issues and experiences that have led me to the conclusion that the FDA's review of Monsanto's rBGH is deeply flawed and completely without credibility.
Our first clear experience with Monsanto involved cow health trials that were being conducted by Monsanto at the University of Vermont.Throughout that process both Monsanto and UVM researchers consistently stated to the public, policy-makers, and the media that there were absolutely no health problems associated with the injection of rBGH into cows.
However, a researcher at UVM began to see a pattern of health problems in cows that had been injected with rBGH. She began to investigate the issue and many of us began to ask questions about the health of the cows. We were never able to gain information about the cows there. When the information was finally published in a journal, we did find that, contrary to all their public statements, the cows injected with rBGH had significantly higher levels of health problems. Also, the researcher who had raised these questions at UVM, lost her job. That was a pattern that you could see developing.
A man named Richard Burroughs, a veternarian who was deeply involved in the target animal safety studies at the FDA, was dismissed from his job at about the same time when he raised questions about the FDA approval process. Dr. Burrows told the media and others that, in our eagerness to approve rBGH, there were serious flaws in the animal safety studies and that potential hazards to people and cattle were not thoroughly assessed. He said that, in addition to the higher incidences of mastitis, cows treated with rBGH had higher than normal levels of reproductive problems and that the FDA did not require the companies to research the problem more thoroughly. That may sound familiar to some of you. He also said that human safety studies were not conducted even though they should have been.
Dr. Borroughs worked on the rBGH review for three years. He said:
I was told I was slowing down the process. It used to be that we had a review process, a Food and Drug Administration. Now we have an approval process. I don't think the FDA is doing good, honest reviews. They've become an extension of the drug industry.
That may also sound familiar to some of you.
In 1991, in responding to questions from Congressman Sanders, the U.S. FDA revealed for the first time to us that they had asked Monsanto to redo its cow safety studies because of potential biases in the results. The Congressman had asked the FDA to compare the results of the cow trials at UVM to those at other test sites. The FDA Centre for Veterinary Medicine said at the time that it did not accept Monsanto's categorization and statistical analysis of these health data because of potential biases in the results when their methods were used. Apparently, Monsanto had only submitted a summary of health problems but no detailed analysis.
Later, at the request of Congressman Sanders, the General Accounting Office of the U.S. Congress also attempted to secure information about the UVM rBGH trials. After a year of negotiations, the GAO abandoned their effort in October of 1992. In a letter to the Congressman, the GAO stated:
-- the inordinant amount of time that has thus far been required to negotiate data acquisition vitiates (undermines) our confidence in the authenticity of the data.
Essentially, the GAO was telling us that they did not trust that any data that they received from Monsanto would be accurate and credible.
In 1992, the GAO did publish a report entitied "rBGH -- Approval Should Be Withheld Until The Mastitis Issue Is Resolved." The GAO confirmed that available rBGH research data showed cows injected with the drug experienced higher levels of mastitis and other problems, that this would lead to an increased use of antibiotics, and that this represented what they called a "secondary" human health threat to consumers. Their concerns have never been resolved even though you will hear about the monitoring process. The General Accounting Office feels that their concerns about antibiotics in the milk have never been resolved.
Under law, the FDA must find that a drug is safe. However, in the case of rBGH the FDA set what we consider to be a very dangerous precedent. They determined that the approval could be based on the finding that rBGH represented a manageable risk. We have no idea what they mean by a "manageable risk" or on what they base this determination.
In meetings and discussions I had with FDA staff, they were unable to define the standard used to make the determination of "manageable risk." There is no mention of "manageable risk" in the law. The assumption appears to be that rBGH will cause an increase in the use of antibiotics, which does represent a threat to consumers, but that the farmer will be able to manage this risk to the public health.
With all due respect to the farm community, a community for which I have a lot of respect, this sets a very dangerous precedent that allows FDA to approve drugs that have not been proven safe and leave it to the farm community to manage that risk. I would argue that, from Monsanto's point of view, it is very beneficial to them as manufacturers to transfer responsibilities for any problems with the drug from their company to the farmer.
As you know, rBGH is a production drug. It is not a therapeutic drug. It does nothing for society, whatsoever. It does not cure disease, it does not benefit consumers or society. Its only purpose is to force cows to make more milk. Given this complete lack of benefit, there should be absolutely no risk at all to consumers from its use.
In 1991, the U.S. Congress Office of Technology Assessment issued a report called: "U.S. Dairy Industry at a Crossroad: Biotechnology and Policy Choices." Dr. Dale Bauman, a Cornell University researcher, who is also a prominent Monsanto consultant, states in that report that there have been absolutely no cases of cow health problems observed in rBGH, going back to the very earliest studies.
This is again a pattern that they have set. I have brought a number of pieces of material from Monsanto, one of which states:
-- to date a variety of academic and industrial research involving hundreds of cows has disclosed no observed differences in body weight, physical condition, susceptibility to disease or overall health.
Another fact sheet states:
No undesirable effects on cows or their calves have been observed.
Another one states:
It appears that the cows simply were unaffected.
Basically, Monsanto is making public statements in all their material that are completely contrary to all the results of the research and completely contradictory to the label insert that is sold with the drug which lists, as you know, about 20 different, potentially very serious, side effects. Yet, Monsanto material consistently says that none of these health effects was found.
Even after the drug was approved and they distributed their technical manual to veterinarians and others, the FDA forced them to make changes in their technical manual. Even after the drug had been approved and all this data had been made clear, Monsanto continued to say that there was no connection between the use of this drug and incidents of mastitis. By that time, we all knew that such a statement was completely false.
The Inspector General of the Agency of Health and Human Services found in two different reports, one in 1991 and the other in 1993, that Monsanto had repeatedly violated the rules that govern pre-approval promotion of a drug. Prior to approval, before they were able to go out and make these kinds of public statements, Monsanto was organizing meetings and workshops at which they were talking to farmers about how well the drug would work, how good it was for cows, and how it would increase their profits. They produced videotapes, brochures and all kinds of materials that were promoting the drug before it was approved, all of which was considered to be illegal at the time. It was part of their effort to push the product on to the market as quickly as possible regardless of what the impacts might have been on either cows or consumers.
I would mention briefly that three high ranking officials at the FDA, who were directly responsible for the approval of rBGH, had very close ties to the Monsanto company. Margaret Miller, a former Monsanto rBGH researcher, was also a high-ranking FDA official. She held a number of positions including "Branch Chief for Hormones and Pharmacological Agents." This branch was responsible for reviewing the human safety aspects of Monsanto's products. Ms Miller, the former Monsanto researcher, originally signed off on Monsanto's rBGH human safety file in 1992. According to the GAO, her signature on the human safety file constitutes participation in the new animal drug application review process and was a violation of the conflict of interest rules in place at the time.
Miller was involved in a number of the important decisions regarding the Monsanto product, including whether it contributed to mastitis in cows, whether the increased antibiotic use represented a human health threat, and whether rBGH could be distinguished from natural BST in milk.
After 1993, Miller became even more involved in the issues surrounding rBGH because of continued concerns about human safety. According to the GAO, the commissioner enlisted Miller's expertise on a number of issues related to human safety. On a number of occasions, she excused herself from these discussions knowing that she had, what she called, an "appearance" problem, which meant an appearance of conflict of interest.
In August of 1993, the FDA was discussing who should address Congress about rBGH, should there be a hearing held after approval. One of the individuals suggested it should be Margaret Miller. Obviously, that was an indication that she knew more about this than anybody else at the FDA. Another individual at the FDA said that she could not do that because she had an appearance problem. That, according to the GAO, was the first time that the FDA commissioner found that she had been employed by Monsanto. He was reported to be visibly surprised to find out that this person, who had been advising him all along on this product, had actually worked for the Monsanto company previously. She also violated the conflict of interests rules seven times. She was publishing articles for Monsanto about rBGH while she was employed at the FDA.
Suzanne Sechen was the primary data reviewer for the product at the FDA. While she was going back and forth to the FDA developing the criteria under which rBGH would be reviewed -- she had three temporary jobs at the FDA -- she was also doing research at Cornell University under the same Monsanto consultant. She did research for Monsanto on Monsanto's products, and sent her results to Monsanto.
After receiving her Ph.D., the first job she obtained was as the primary data reviewer for this product at the FDA. Ms. Sechen got there so fast, she was reviewing her own data and that of her mentor. Her mentor is the person who said that no cows had ever become sick from this product, thus contradicting everything we know. You would assume that she picked up some of her mentor's ideas. The FDA believes this situation could have raised some questions about her objectivity.
Ms. Sechen also violated the FDA conflict of interest rules on three occasions when she published articles for Monsanto while working for the FDA. The article lists Margaret Miller, the researchers, Monsanto, and then there is an asterisk indicating the current address of the Food and Drug Administration.
In 1998, the Government Ethics Office did an evaluation of the FDA. When looking at the rules for their approval officials, they found that most of them did not understand the distinction between official duties and outside activities. They are saying that the people at the Food and Drug Administration in the United States do not know the difference between working for the FDA or corporations that might be their previous or future employers.
I should mention briefly that Michael Taylor, the FDA Deputy Commissioner for Policy at the time, had also been Monsanto's attorney before coming to the FDA. While he was not directly involved in approving the drug, Taylor signed off on the FDA's decision not to allow consumer labelling of the drug. Moreover, he was deeply involved in the review of issues concerning labelling.
I had the opportunity to meet with Dr. Kessler -- who was the FDA commissioner at the time -- and other staff members, in order to discuss issues that are part of the gaps analysis debate. Some of the issues discussed refer to the lack of long-term human safety studies, the potential for rBGH to be absorbed into the bloodstream, and the possible impact of consuming higher levels of insulin-like growth factor 1 in the milk of these cows. They all agree that there were significantly higher levels of IGF-1 in the milk from rBGH injected cows.
We were told that this poses no health concern, however, because the IGF-1 would not survive digestion. Both the American Medical Association and the National Institute for Health in the U.S. indicated the need for further studies to establish the long-term effects resulting from consuming milk from rBGH injected cows, because of the higher levels of IGF-1.
That the FDA never did long-term research, because both the FDA and Monsanto claimed the product would not survive digestion. However, the gaps analysis indicates, as we knew from earlier research, that the IGF-1 could survive digestion, especially if consumed with milk protein. The other major conclusion in the gaps analysis that concerns us is the 90-day rat study by Monsanto, which the gaps analysis courteously referred to as "misreported."
If that is true, then Monsanto and/or the FDA covered up the most important safety study. When I asked Dr. Kessler about the lack of long-term human health studies, I was told that the short-term studies showed no need for long-term human health studies. However, when I enquired whether there would be residues of synthetic hormone in the milk of these cows, he said yes.I asked how much synthetic hormone would be in the milk from those cows, and he answered that he did not know, because his staff had told him they did not have to look into that.
We believe the staff member who told him that, was Margaret Miller, the former Monsanto researcher who had violated conflict of interests rules. In effect, Dr. Kessler admitted that his staff told him that we did not need to know how much residue of synthetic hormone would be in the milk, and that it would not survive digestion. Based on what Health Canada has found, that may not be true.
We also know from a number of memos and from these discussions, that the FDA relied heavily on the 90-day rat test when concluding that rBGH would not be absorbed, and that there would be no need for long-term human safety studies. That study was cited in Science magazine, and in all the discussions we had with them.
In closing, I would like to point out that we, in Vermont, have asked our own U.S. congressional delegation and state legislators to request information from the FDA as a result of the gaps analysis. They are in the process of doing that. We have also asked them to open an investigation into the Food and Drug Administration review of the human safety issues surrounding rBGH.
U.S. laws indicate that the FDA must reconsider a drug, and revoke a company's right to market it if there is new evidence that a drug has proven to be unsafe. We believe the gaps analysis provides appropriate new information and evidence indicating that the drug's review must be reconsidered, and that Monsanto's licence to market the product should be suspended until adequate research into long-term human health effects are conducted.
We urge you to continue your efforts here, and not to make the same mistakes that were made in the U.S. I believe the researchers who compiled the gaps analysis have taken a courageous step forward in trying to tell the truth about what they have found.
For years, this kind of information has been covered up. A group of British researchers found that Monsanto skewed data in order to downplay the negative effects on cows, as presented in research Monsanto did on the drug, and which concluded that it had no negative effects on cows. Monsanto has a habit of pooling data and doing small tests from which it picks and chooses to determine the effects on cows.
Together, we can do three things. First, we can restore some integrity to the drug approval process in both the U.S. and Canada, thus restoring public faith in these institutions, which are controlled more and more by corporations. Second, we can guarantee the safety of this product for consumers and cows alike. Third, we can protect the integrity of the great majority of dairy farmers who do not want to use rBGH, and who do not want chemical companies like Monsanto gaining control over their industry and their products.
It is very important that Canadians and Americans cooperate in this effort. Do not make the same mistake the FDA made. Potential survival of IGF-1 in the system is suspected. Monsanto said it would not happen; it will happen. They also said that rBGH would not be absorbed into the bloodstream, but evidence to the contrary can be found in a previous study made by another company. I look forward to continuing to work with you senators and others here in Canada to resolve these questions for the benefit of the U.S., Canada, farmers, and consumers.
The Chairman: We will hear the statements, and then go to questions.
Ms Nelson: Thank you for the opportunity to share some of my insights and observations as a dairy farmer, Rural Vermont Board member, and state legislator. My husband Bill and I own and operate Home Acres Farm in Ryegate Corner, Vermont. We milk 150 Holstein and Guernsey cows, and have about the same number of replacements. We own 600 acres and crop other land as well. Our two grown sons, who farm with us, are the eighth generation to farm our land.
We first heard about the bovine growth hormone in the late 1980s. Our first thought was to question why farmers would want to make more milk, when we knew that every time a surplus was reported our milk prices crashed. Why would any farmer want to give his cows shots unnecessarily? Further, if cows were stressed to make even more milk than they had been making, would we not have more mastitis to deal with? Finally, would it be worth the risk to tamper with a pure, wholesome, and natural product?
Up until this time, while our children were small, I was called a self-proclaimed milk promoter. I figured if I could get every person to drink one more glass of milk each day, our problems would be solved. The surplus would be gone, our milk prices would go up, and we would all live happily ever after. To my way of thinking, though, getting more milk by injecting BGH into cows was not going to help us out financially.
Bill and I joined Rural Vermont, a farm and rural advocacy organization. I was impressed with the farmers who belonged to that group. They were thinkers and doers. Many farmers were mesmerized by the high-tech corporate mentality of expansion in the 1970s and efficiency in the 1980s, answering the call for cheap food. We asked ourselves why we, with our valuable skills for producing food and our big investments in land and machinery, found ourselves in a survival mode with little power or influence.
Now, I am not a renowned scientist, and I am not a national economist, but common sense tells me that deception for profit is the name of the game in this bovine growth hormone debate.
Monsanto underwrote four BGH research studies at the University of Vermont, my alma mater. In 1990 an employee from the university provided Rural Vermont with information and photos showing that BGH-treated cows were giving birth to deformed calves and experiencing severe health problems. Our organization produced an initial report on the animal health of the Monsanto-UVM test herd in 1991. The POSILAC package insert now confirms that Rural Vermont correctly identified six of the 21 side effects for cattle treated with BGH.
We persisted over the next four years in following the flawed FDA approval process, and two reports were published in 1995. I believe you may have copies of these. One is "Recombinant Bovine Growth Hormone: Alarming Tests, Unfounded Approval," and is the story behind the rush to bring rBGH to market. Andrew Christiansen wrote that. The second report was "Down on the Farm: The Real BGH Story," by Mark Kastel from Wisconsin.
The Chairman: I do not believe we have those reports. Perhaps you could table them.
Ms Nelson: We have extra copies.
It was deception for profit. Farmers were told, "If you are a good producer, this is a great management tool and it will increase profits. A good producer's introduction to POSILAC. It is simple and quick, and it is the single most tested product in history."
Following our 1991 report, the FDA revealed to our United States Congressman, Bernie Sanders, that there had been an outbreak of mastitis in the first trial at UVM. Four hundred and fifty per cent more cows in the BGH group had been treated than in the control group, and the rBGH group had 725 per cent more new cases. The FDA summary of many pooled studies showed cows receiving rBGH had a 79 per cent greater risk of getting mastitis than untreated cows.
Along with a video comes this POSILAC pocket guide to success. This handy pocket guide to success provided by Monsanto charts out the way to calculate profitability. It is on the last page. No where in the chart of expenses does it list the lost production and additional costs for antibiotics and veterinary care incurred by mastitis. It states, "Just feed more" and "it works." However, they forget to mention that more feed means more manure to manage as well, which means more land, or there will be too many nutrients on our limited land base. I would say an average case of mastitis costs a farmer, if a veterinary cost is not included, about $150.
Rural Vermont's report "Down on the Farm: The Real BGH Story," tells of the actual experiences of farmers with serious herd health problems. The vets in our own town have refused to get involved with Monsanto's $150 voucher program. They told me recently that only four out of 125 clients use rBGH.
This past year, we at Rural Vermont did a study of milk handlers. Given that we have the BGH labelling bill, we determined that 96 per cent of Vermont dairy farmers do not use rBGH, and with good reason. We are in the market-driven 1990s. Consumers want to be able to choose rBGH-free products. Eleven of the 14 dairy processors make that claim. They can do this because the Vermont legislature passed the voluntary BGH-free supply of milk law. Farmers sign affidavits, and the commissioner of agriculture verifies the claim.
A few years ago, Vermont had the first mandatory BGH labelling law in the nation. That meant that any product that might have BGH in it had to be labelled. We had blue dots and all kinds of stuff. However, in the courts it was determined that Monsanto's freedom of speech was more important than the consumers' right to know. This new law, though voluntary for rBGH-free products, was no easy task. Monsanto sent letters to farmers threatening to stop doing business in the state of Vermont if they had to be licensed. Their lobbyist lawyers sent letters to legislators, and even told the commissioner of agriculture what they wanted in the law. Three top executives flew in to Montpelier to persuade the governor to veto the bill.
Vermont is the most dairy-dependent state in the United States. We make more milk per capita than any other state in the country, and we have consumers who want rBGH-free products. We are home to Ben and Jerry's ice cream and Cabot cheese.
Farmers must meet the demand for rBGH-free products. People care about their health. They are concerned about bio-genetically engineered foods. I believe dairy farmers are independent businessmen and women who take pride in producing natural products for a consuming public. The multinational chemical corporation of Monsanto, looking for a return on a sour investment, has preyed on hard-working farmers. This simple and quick management tool has spawned controversy and raised serious concerns about human health problems. You in Canada would be wise to stay away from this deplorable product, whose social and economic consequences are so destructive.
The Chairman: Thank you, Ms Nelson.
Please proceed, Mr. Hansen.
Mr. Michael Hansen, Ph.D., Research Associate, Consumers Union, Consumer Policy Institute: Honourable senators, I am a research associate with the Consumer Policy Institute, a division of Consumers Union of the U.S., publisher of Consumer Reports magazine. We are the largest consumer organization in the United States. We do a lot of product testing. Our magazine has approximately 4.5 million paid subscribers, and is the second largest monthly magazine in the U.S.
I have been involved with this rBGH or rBST issue for about 10 years. In 1994, I also appeared before a committee on agriculture here in Canada. I was the one who brought data on rBGH here from England and distributed it.
I wish to talk about two things; the gaps analysis report and JECFA, the Joint Expert Committee on Food Additives.
We are extremely concerned that, according to the gaps analysis report, the 90-day feeding study found that 20 to 30 per cent of the rats in the higher dose groups developed antibodies to rBST, which suggested they were absorbing rBST. In addition, the report cites cysts on the thyroids of male rats and some increased mononuclear infiltration in the prostate.
These findings call into question the entire basis of the U.S. Food and Drug Administration's determination that rBGH is safe for human use. The results of the 90-day study were misreported by the FDA in the 1990 Science magazine article that laid out their rationale for stating that rBGH is safe. The article discussed this 90-day feeding study in some length, and even included two tables of data. Yet they concluded that there were "no toxicologically significant changes" in the rats that received rBGH orally.
The fact that there were antibodies, and these other results, should have triggered longer-term studies, but the U.S. FDA took no action.
We believe that the 90-day study is of crucial importance and that the full study should be released for independent appraisal by both Canadian and American scientists. First, as pointed out in appendix VI of the gaps analysis report, which is called the "Monsanto study on Immunoglobin in Rat Serum," the rationale for looking at antibodies in the first place was because a previous rat study had found similar effects. According to that study:
The examination for antibodies was prompted by reports of detection of circulating anti-BST antibodies in hypophysectomized rats administered pituitary BST orally or by injection.
Monsanto's 90-day study made up for the defects in the first study by using normal, that is, not hypophysectomized rats, by using Monsanto's rBGH product, sometribove or POSILAC, and by doing more careful antibody measurements. The study clearly found antibodies from Monsanto's rBGH.
Second, the fact that the 90-day study also found antibodies for rBGH in the sera of rats orally administered rBGH suggests that this is a real rather than an anomalous result, and that rBGH had been absorbed; that is, it had survived digestion.
Dr. McLean from the Joint Expert Committee on Food Additives was brought in at this point. He tried to explain away the antibody results using two arguments: one, that the immune response to dietary intake of food is common; and two, the use of stomach tubing in rats could lead to small amounts leaking into their lungs, where it would be absorbed systematically to generate antibodies. While it is true that circulating antibodies to food proteins such as milk or albumen in the diet can be generated, laboratory studies show that you need relatively large amounts of foreign food proteins to induce this response. With rBGH, only very small amounts, five milligrams per kilogram per day, were needed.
Further, if the immune response to dietary intake of proteins is so common, why was the experiment done in the first place, and why were the results of the hypophysectomized rat study considered problematic? As for the argument that the antibody response is due to small amounts of the rBGH being inhaled rather than digested, if so, one might expect the same percentage of rats in each oral dosage group to inhale material. In other words, the discomfort caused by the stomach tubing would be the same for all the rats at all dosage levels, and one would expect the same pecentage of rats in each dosage group to exhibit antibodies. This is not what the data show.
At week 14, the data show that there is a trend toward an increasing number of rats with circulating antibodies at increased oral dosage of rBGH. Thus, for rats that were given .1 milligrams per kilogram per day, .5 milligrams per kilogram per day, 5 milligrams per kilogram per day, and 50 milligrams per kilogram per day, the results were: one out of 30, zero out of 29, six out of 30, and 9 out of 30 respectively. This suggests that it is the concentration of rBGH, and not just the discomfort caused by the stomach tubing, that is important. These data are consistent with the hypothesis that some rBGH does survive digestion and is absorbed intact.
In summary, we believe that the finding of antibodies to rBGH in the Monsanto 90-day rat feeding study corroborated what was seen in the earlier study with pituitary BGH and hypophysectomized rats, and that this is a real result. In addition, a finding of cysts on the thyroid of male rats and mononuclear infiltration in their prostates when administered rBGH orally are also troubling.
We strongly agree with the authors of the gaps analysis report that these results should have triggered longer-term studies. After all, it is standard procedure for most animal drugs to perform a full toxicology package, including two-year carcinogenicity studies and three-generation reproduction studies, particularly if short-term studies find an effect.
In the U.S., we have called for an explanation of why Monsanto has never publicly revealed the results of the 90-day feeding study; why the U.S. FDA misreported the data in 1990; why they failed to include or even refer to them in the freedom of information summary on POSILAC released in November 1993; and why they did not require Monsanto to conduct longer-term toxicity studies.
We have also asked the U.S. Congress to investigate these questions and to urge the FDA to immediately release the full 90-day rat feeding study, if they have it. We have also urged Congress to obtain an independent analysis of the 90-day study; to study the full gaps analysis report; to meet with the members of the rBST internal review team that prepared the gaps analysis report; and to demand an immediate response from Monsanto and the FDA on these issues.
At the October 29 hearing of the committee, Dr. McLean testified, among other things, about the 50th Joint Expert Committee on Food Additivies meeting in February 1998, where rBGH was discussed. JECFA does not seek to achieve consensus among governments or organizations, and everyone attending the meetings serves in a private capacity as an "international expert," either as a full member, a temporary adviser, or a consultant. I served as a "temporary adviser," based on my expertise in the area. I was also the lead author on a technical paper, "Potential Public Health Impacts of the Use of Recombinant Bovine Somatatrophin in Dairy Production," that Consumers International submitted for consideration at the 50th JECFA meeting. I have brought extra copies for everyone on the panel.
Dr. McLean testified on October 29 that he believed I was satisfied both with the data that JECFA looked at as well as the way that they reported it. This is not true. I have serious concerns about the process and I do not agree with the conclusions. Although the final report is supposed to be a consensus document, in fact it is not. Under the rules of the committee, I am not at liberty to discuss what was said at the meeting. However, I am free to discuss the members of the committee and the substance of their report.
First, I believe there are certain facts that you should know about the experts who made up the two JECFA panels that reviewed rBGH. The first panel, which met in 1992, included, as a member, temporary adviser, or consultant, six officials from the Centre for Veterinary Medicine of the FDA, which had previously ruled that dairy products from rBGH-treated cows were safe for human consumption. One of the officials, Dr. Margaret Miller, had been involved in the FDA determination that rBGH was safe. Dr. Miller's previous position before joining the FDA was as head of the Monsanto laboratory that produced much of the research data on human safety on rBGH. We believe Dr. Miller had a serious conflict of interest and cannot be regarded as an independent expert.
Also present at the 1992 JECFA assessment as temporary advisers or consultants were Dr. Greg Guyer and Dr. Judith Juskevich, the two FDA officials who authored the paper in Science that misled the public about the 90-day rat feeding study. The other U.S. FDA participants at the so-called "independent" assessment by JECFA were Dr. Gerald Guest, then director of the Centre for Veterinary Medicine, and Dr. Robert Livingston and Dr. Furrow, both with the Centre of Veterinary Medicine. In addition, Dr. Len Ritter of the Bureau of Veterinary Drugs within Health Canada also attended this meeting. I am sure you are all well aware of the controversy surrounding Dr. Ritter's appearance in 1994 before the Canadian committee on agriculture when it was investigating rBGH.
Partly due to lobbying by Consumers International, the question of human safety of rBGH was referred to JECFA for a second time in 1997 by the Codex Alimentarius Commission.
JECFA met in February 1998. The rapporteur at that meeting was Dr. Margaret Miller, and one of the co-authors of the report from that meeting on rBGH was Dr. Nicholas Weber, also from the Centre for Veterinary Medicine, who reports to Dr. Miller. Dr. Len Ritter again participated in the 1998 panel.
I disagree with the results and conclusions of the JECFA report in three critical areas. The first is increased mastitis levels in rBGH treated cows, leading to increased use of antibiotics. The second is the potential health impacts from increased levels of IGF-1 in the milk. The third is the possibility that rBGH use increases the risk of BSE.
We have concerns that rBST use increases the instance of mastitis, as was found in both the pre-approval and post-approval studies. However, JECFA declared that the question of whether rBST use increases mastitis was outside the purview of the committee, and thus there was no discussion on this issue.
As for antibiotic residue, JECFA stated that in the United States, there were:
-- insignificant changes in the quantities of milk discarded due to antibiotic residue testing after the introduction of rBST into commercial use.
We disagree with this conclusion for a number of reasons.
First, we believe that the one study cited in support of this conclusion, the post-approval monitoring program, or PAMP, was fundamentally flawed. No data were taken on the actual antibiotic residue levels in the milk of treated and untreated cows, meaning there was no direct evidence on antibiotic residues in milk from treated cows. Without such direct evidence, no strong conclusions can be drawn on whether there is an increase in drug residues in milk. Rather than looking at direct evidence, the PAMP study simply looked at the percentage of milk discarded due to violable antibiotic residues. However, the PAMP study did find a statistically significant increase in violable antibiotic residue levels in the key dairy states in the year following approval of POSILAC, Monsanto's rBGH product. The PAMP looked at 1992 and 1993, the two years before approval, and 1994 and 1995, the two years after.
JECFA and the U.S. FDA have claimed that the significant increase can be explained by a change in residue testing methods. Part of the PAMP included a program of tracking antibiotic residues in the 12 states that were responsible for over 50 per cent of the total U.S. milk supply, both before and after commercial sales of POSILAC began in February 1994. The percentage of milk discarded in the two years prior to the launch of POSILAC was .05 percent. After, it was .06 in 1994, and .09 in 1995. The data show a statistically significant increase in the discard rate of milk for 1995. Coincidentally, most states did change their testing procedures in 1995 to include a more sensitive screening test, and JECFA concluded that the 50 per cent or 80 per cent increase in discarded milk was due to that switch. This conclusion was based on the situation in New York State, which used the same testing protocol for the entire four-year period, and where the pre-approval percentage of discarded milk was .062 per cent, compared with a post-approval rate of .064 per cent.
Furthermore, Monsanto asserted that rBST was being used on over 37 per cent of farms in New York State, which represents about 50 per cent of the cows, although they have refused to reveal the precise number of doses of rBGH sold there in 1994 and 1995. We disagree with the analysis of this discard data. In order to use the New York data to argue that the statistically significant increase is all due to a switch to a more significant test, and not rBGH use, it is crucial to know exactly how many doses of POSILAC were used in 1994 and 1995. I have included a discussion paper in the appendix showing that while Monsanto has refused to release sales and use figures, until mid-1995, there was a legal requirement in New York State for farmers to acquire a certificate of need for a syringe from the state health department. Only 700 farmers applied in 1994 and 1995 for a certificate of need, and even if we assume that all of them received a certificate and were using rBGH, that is 700 out of 10,000, or 7 per cent of all farmers. If 50 per cent of farmers were really using it, that means there was massive violation of the law going on in 1994 and 1995 in New York. I even did an analysis of their first year's sales figures, where if it were true that 50 per cent of the cows in New York were treated, 75 per cent to 80 per cent of all the doses sold in the U.S. must have been in that state.
Data were kept on the antibiotic use levels for the test herds, and we have always said that is what should be done. The data from both pre-approval and post-approval studies show increased use of antibiotics. In a study of 15 commercial test herds using POSILAC, there was a 46 per cent overall increase in mastitis, and antibiotic treatment doubled in the rBGH-treated cows compared with controls. In the PAMP studies, the total duration of antibiotic treatment for mastitis was 89 per cent higher, or 402 days versus 212, in primiparous rBGH-treated cows compared to controls; and it was 34 per cent higher, or 982 days versus 743, in multiparous cows. Both effects were highly statistically significant.
In spite of the fact that both pre- and post-approval studies showed increases in total duration of antibiotic treatment for mastitis, JECFA chose to focus only on the amount of violable antibiotic residues. While such data are useful, we feel the best data are the actual levels of antibiotic residues in milk from rBGH-treated and untreated cows. However, such data have never been gathered, or at least never been made public, either in the pre-approval studies or in the PAMP study, despite calls from the U.S. General Accounting Office in 1992 to develop such data.
In a letter to then Human Health and Services Secretary, Donna Shalala, following up on the FAO 1992 report entitled, "Recombinant Bovine Growth Hormone: FDA Approval Should be Withheld Until the Mastitis Issue is Resolved," the GAO inspector general stated:
-- if rBGH use does result in increased antibiotic milk concentrations, current withdrawal and withholding requirements may well be inadequate to deal with such considerations. Consequently, without having answered the empirical question of what antibiotic concentrations would occur, the assumption that withdrawal and withholding requirements eliminate the antibiotic food safety concern cannot be made. Simply put, your response did not address our concern: does rBGH use result in higher concentrations of antibiotics in milk or not, and if so, is the higher level acceptable from a food safety standpoint? Conducting antibiotic assays between control and treatment groups to address the above question would seem to be a better approach than assuming that current withdrawl and withholding requirements are sufficient to resolve a problem whose likely size and significance remain uninvestigated.
That letter concluded:
-- that the increase in mastitis levels reported in the rBGH pivotal studies suggests that the potential for an increase in milk antibiotics is very real. The approval of rBGH products should not be forthcoming until the antibiotic risk is validly assessed. The Department's response suggests that our recommendations have not been seriously addressed.
These questions have still not been seriously addressed some five years later.
I will summarize the information on IGF-1 levels in milk, although there are a number of pages in the presentation where I go into detail. As to the question of levels of IGF-1, a natural hormone that is also a tumour promoter, in milk from treated cows, the JECFA argued this is not a problem, due to "low residue levels of rBST and IGF-1 in milk" and to "the degradation of IGF-1 in the gut and its abundance in gut secretions."
That minimizes the fact that in 1998, JECFA actually changed its position from 1992.
In 1992, the committee had concluded that some studies suggested that rBST treatment might produce a slight increase in average IGF-1 concentrations, but it also stated that the most definitive and comprehensive studies showed that IGF-1 concentrations are not altered after rBST treatment. Yet the data in that report actually showed that for the longest studies, which were Monsanto's, there was a statistically significant increase. However, the 1998 JECFA study assumed a 50 per cent increase.
They then tried to explain away that increase at first by pointing to a post-approval study that looked at IGF-1 levels in retail milk, but only at levels in milk that was labeled as not being treated with rBGH, and unlabeled milk. Since the study did not bother to determine what percentage of the unlabeled milk came from cows treated with rBGH, you cannot say anything conclusive about the lack of a statistically significant difference between IGF-1 levels in labeled and unlabeled milk. In fact, over two-thirds of the milk was from Wisconsin, which has perhaps the lowest use of rBGH of any of the major dairy states. Indeed, as was pointed out, University of Wisconsin experts estimated that between 2 per cent and 3 per cent of Wisconsin cows were getting rBGH as of December 1994 and this milk was sampled in the same year. With such minimal use, we would not expect to see any significant difference between labeled and unlabeled milk, and that retail milk study is completely worthless.
They also stated that while there may have been an increase in IGF-1 levels, and even admitted that there are studies that perhaps show that it survives digestion, there is so much secreted by the gastrointestinal tract that that would not be a problem. They estimated that drinking a litre and a half of milk per day adds approximately 2.3 per cent of the total amount of IGF-1 in the gastrointestinal tract, and the extra IGF-1 in the milk from rBGH, if you assume the 50 per cent increase that the data appear to show, is responsible for a 0.8 per cent increase.
I will just point out that a previous study had shown that IGF-1 in its free form is digested in the intestinal tract within two minutes. In the presence of casein, it takes over 35 minutes, or 17 times as long. Thus, it is misleading to just look at the total quantity of a hormone and say that it is less than 1 per cent and therefore not significant. For some people that would be significant, and the fact that it is being protected by digestion is another story.
Finally, I will briefly mention the fact that the committee paid little attention to the potential connection between IGF-1 and increased susceptibility to BSE, and you can read and hear why we think this is a problem. They basically said there is not a definitive link. We agree with that, but we also think that because of the precautionary principle, and given the potential downside of BSE, they should have required research to be done in this area.
I will finish by saying that we see sufficient scientific data related to human health issues to support taking a cautious approach on rBGH use. JECFA says that rBST can be used without any appreciable risk to the health of consumers. We disagree with this characterization, and feel that since there are so many important, unanswered questions that should be researched, the true risk cannot be accurately defined at this point. We also ask why it is necessary to take any risk with a product for which there is no real need, and I call on this committee to continue to look into it. I salute the scientists from Health Canada who did the gaps analysis report, and who are putting their careers on the line to help publicize some of the problems with this product.
The Chairman: Dr. Hansen, you have a report to submit?
Mr. Hansen: Yes.
Senator Whelan: We have already heard, if not exactly in the same form, much of what has been presented by the witnesses today. My first question is for Ms Nelson.
I have noticed that the humane societies in your country and ours take a neutral stand on injecting a cow with a hormone that changes her system and makes her give more milk. If we did that in the horse racing industry, gave a horse a shot to make it run faster, or gave a shot to our cat to make it jump higher, the humane society would be very alarmed about that. Why are they not concerned about the effects of this on an animal, considering the changes to its system, such as making it eat more, making it produce more, making its hair fall out, and so on?
Ms Nelson: Mr. Pollina tells me the U.S. humane society is opposed to bovine growth hormone.
Senator Whelan: We cannot find any official opposition to it.
Ms Nelson: We can get you some information on that, but cows are our bread and butter, and there is no way that we will do anything to jeopardize our business. I feel very strongly about that whole issue.
Senator Whelan: What concerns me is that you did not say anything in your presentation, nor did the other two witnesses, about the official position of the United States humane society. In Canada they say they have no position. If it is anything, it is neutral.
Mr. Pollina: We can provide some information from the U.S. society.
Senator Whelan: I want to know if you can provide their official stand. I am amazed that you do not know if they have one.
Mr. Pollina: I have seen their material voicing opposition.
Senator Whelan: But do they take an official stand? In 1994 the Canadian Veterinary Medical Association said they more or less approved of rBST use, but now they say that was not an official position. I am concerned about these official and unofficial positions. We would like them to be more upfront.
When you were dealing with Monsanto, Ms Nelson, as a dairy farmer, did the agents come right to your farm and try and sell you on the benefits of their product?
Ms Nelson: They did not come directly to our farm, but we received several invitations to nice meetings with big dinners.
Mr. Pollina: We also found that they invited many farmers to meetings, and at one point there was a report that they had paid dairy farmers to attend a meeting to learn about the benefits of rBGH. The extension services of our USDA were also found to be helping to pay for dinners sponsored by Monsanto, which is a conflict issue.
Senator Whelan: Can you give us a little more detail on labeling in the United States? Do the states have the authority to label or is that under federal control?
Ms Nelson: We have an individual right as a state to enact a voluntary BGH labeling law. We must have a disclosure on the label stating there is no significant evidence of problems with the bovine growth hormone. It is our understanding that there are several other states with similar legislation.
Senator Whelan: What is the law in your state?
Ms Nelson: Our law states that farmers must sign an affidavit if they are not using the bovine growth hormone and submit it to their processor. The Commissioner of Agriculture is informed of any concern that a farmer is not being truthful. He sends out inspectors to investigate, maybe to check the refrigerator for POSILAC, or to look at the milk production records to see if there has been a significant increase.
Finally, if all the information indicates that the farmer has not been truthful, that puts the processor on the line, because he is advertising that his milk is BST free. This gives the commissioner the right to subpoena information about the sale of bovine growth hormone to that farmer, and that upsets Monsanto.
Senator Whelan: Do you actually have labelling on your containers of milk and dairy products stating that the product contains rBST-free milk?
Ms Nelson: Yes.
Senator Whelan: How many states have that?
Ms Nelson: I believe there are about nine or ten.
Senator Fairbairn: Is that voluntary?
Mr. Hansen: I have testified in all the states where this question has arisen. A number of states have passed voluntary labelling laws but other have not. For example, there is no current law in New York, but you can buy Farmland Dairies' milk, which carries a label stating that their farmers do not use this product and do not agree with it.
The whole question of labelling becomes interesting because the FDA has abdicated their responsibility. We believe that all milk should have been mandatorily labelled, because there is a difference. However, the FDA said that they could not require mandatory labelling. They then drew up this voluntary labelling law that said, "Yes, you can you can do that, but you cannot mislead people." The legislation was approved by Michael Taylor. Subsequently, a law firm sent thousands of letters to all sorts of small, natural food stores and other stores, pointing out that if they sold voluntarily labelled products, they could not guarantee the rBST-free claim. Therefore, the milk might be mislabelled and the stores could still be liable in a lawsuit. They sent out thousands of these threatening letters and then launched two lawsuits: one against the Pure Milk and Ice Cream Company in Waco, Texas; and one against Swiss Valley Farms in the central part of the country. Both of those cases were settled out of court.
Senator Whelan: Can you move dairy products freely across an invisible state boundary?
Mr. Pollina: Yes.
Senator Whelan: There is no control on those products?
Mr. Pollina: Not relative to this kind of labelling, no. Vermont products that might be labelled "rBST free" are still sold around the region.
Senator Whelan: We have been doing a comparison on butter prices, for instance, and last year at this time, butter was on special in many stores. I live right next to the American border, and in Port Huron, it was on special for 97 cents to entice you into the store. This year, it was US$3.39 a pound. In Canada, that is equivalent to about $5.60. If Monsanto was doing such a great job with this hormone, why did you experience a butterfat shortage?
Ms Nelson: I do not know.
Senator Whelan: We have no dairy shortage in our country, yet Monsanto has said there is a shortage of dairy products. Do you have a shortage on your farm?
Ms Nelson: No, we do not have a shortage of milk. We have tried to maintain the same average size herd. With two sons at home now, we have increased our herd by 20 cows over the last four years.
I envy you folks in Canada with your quota system. Some of your farmers may think that it is very expensive, but in Vermont we are fortunate to have this compact that is talking about the possibility of some supply management. It puts a stabilizing price on fluid milk. I had an opportunity to meet with your Quebec dairy farmers' federation the morning after they worked into the night to negotiate a price for the whole year. In Vermont, we receive a milk cheque every two weeks, but we do not know what the price for our milk will be.
Senator Whelan: You are marketing your product in a medieval fashion, are you not?
Ms Nelson: That is right.
Senator Whelan: How can American farmers be so behind the times? We have had this system for about 20 or 30 years in Canada, and they have it in Europe, too. I believe we developed it first, but it was not done by my industry. Senator Hays's father organized that. He was an Alberta farmer who raised beef and grain, and he saw the unfairness in the industry, and did something about it. When you talk about Quebec, remember that that dairy commission was created within the two concepts of Canadian federation. Quebec farmers received 30 per cent or 40 per cent less for their product than farmers in other provinces, so they travelled from coast to coast, that is, about 4,000 miles, to organize the Canadian Dairy Commission. They raised their standards to equal par for their milk that was being processed into cheese and other products. The industry is on the same plateau as far as health and hygiene and similar matters are concerned, but it took a long time to do that.
We are being threatened with the destruction of that system. No political party has asked for a change, but big business and the bureaucrats have arbitrarily decided that we must change it because it is too successful. We do not have the chaos in our dairy industry that we have in both our pork and grain industry.
I wish to ask Michael Hansen his opinion of Codex, because I have strong reservations about it. Recently, the Department of Health announced a delay in announcing rBST until next June. I am suspicious that this has something to do with Codex. Some of our officials voted with Codex without authorization from any of our ministers or top government people. Australia and New Zealand voted with the United States, yet they ban rBST in their own country. I find some of their actions to be hypocritical, at the very least.
Mr. Hansen: I agree with you. When they say that they will wait until June, they mean that rBST will be raised again before the Codex Committee on General Principles in March. It will then go before the full Codex commission for a vote in June. That is highly controversial, because the Codex Committee on Residues of Veterinary Drugs in Foods met in September. That was two weeks before the Codex Committee on General Principles met in Paris and came to a clear conclusion that there must be consensus before products are pushed out of the committee level and up to the commission level.
The Europeans have said they heard that the chairman stated there were no scientific objections based on the JECFA report. That is true, but the Europeans and others were saying that we cannot talk about the science until we have the final technical report. They wanted to put off discussion until the next Codex Committee on Residues of Veterinary Drugs in Foods met. In fact, for a number of other drugs where the final data was not in, that is, where they did not have the report from JECFA, they decided to wait. Yet they decided against that approach with this drug.
The chairman of the Codex Committee on Residues of Veterinary Drugs in Foods is the present director of the Centre for Veterinary Medicine of the FDA. In 1993, he headed the Veterinary Medicine Advisory Committee that made the decision that the mastitis problem was a "manageable risk." He stated that Canada and Australia have said that it should be pushed forward, and a number of other countries, such as Honduras, Nicaragua, Brazil, and Argentina agreed. However, there were strong reservations from the Europeans, who had eloquent arguments against talking about the science until the final report from JECFA became available. They were not willing to just rubber-stamp this. Finally, it came down to a 12 to 12 vote, but the chairman cast his vote in favour of moving it on.
I predict that, for Consumers International and for a lot of other people, there will be considerable controversy at the next two Codex meetings. I think that this 90-day study will be very much in the limelight at the Codex meeting and will probably raise important questions. It will be interesting to see what happens.
Senator Spivak: I take it from what we have heard today that there was no huge outpouring of demand for this drug to be brought to the market, as there is in Canada.
Dr. Hansen, regarding JECFA, can we safely assume that there are serious concerns with the membership, and also the Codex Alimentarius, related to their previous activities?
In a press release last June, JECFA stated its opinion that there were no food and safety health concerns, but that release was later withdrawn. That has not really come to the forefront. Was it the FAO that withdrew that release or the World Health Organization? I am not clear on that.
I have here the record of understanding between the Governments of Canada and the United States of America regarding areas of agricultural trade, dated December 2. With regard to veterinary drugs, the statement says that both the United States and Canada have stringent, scientifically based programs for the pre-market approval of veterinary drugs. It refers to some differences in regulatory approaches, but maintains that outcomes are essentially equivalent in the protection of public health in the two countries.
Please comment on that statement, which worries me in view of what we have heard about the FDA process.
Also, the gaps analysis talked about the impact on neonates, but as I understand the JECFA assessment, that issue was never examined. We know that issue is important because children drink more milk, and based on their size, any intake has a greater impact than it would on adults.
Mr. Hansen: Regarding the makeup of the JECFA committee and the Codex Alimentarius, yes, within the non-governmental organization community, there are concerns. We feel the nomination process should be far more transparent and that there are conflicts of interest. They tried to argue in 1993, when we were fighting in the U.S., that this is an independent group approved by the FAO. It was not until we saw who was there that we realized they were the same cast of characters who were pushing it through here.
When they first looked at it in 1992, even though they had their own data, they stated that IGF-1 is not increased in milk and is perfectly digested. Yes, I do have serious concerns with that.
I am glad you brought up the press release, because it was very upsetting to me. In fact, I was one of those who started all of this. Someone sent us that press release. I went through the roof when I saw it, because it contains a purported quote from the committee's findings that there is no effect whatsoever, but which is found nowhere in any of our reports. That quote was fabricated. Furthermore, the report said the committee looked at things like the mastitis issue, which it did not.
I immediately sent e-mails to everyone on JECFA and to the rapporteurs. I demanded, and hoped everyone would agree with me, that the press release be withdrawn and a corrected release issued.
I received a message from someone who was with the secretariat for JECFA, which is joint WHO and FAO. It was put up on the FAO Web site. He said he did not even know there was a press release. In his e-mail to me, he said there had been an agreement, since they put the summary up on the Web site, that there would be no press release, and that furthermore, if there was a press release it would have to go through WHO as well. He had never seen it.
Within two days, he notified me that it had been removed from the Web site. That raises an interesting question as to how the press release got up there. They found absolutely nothing about where the quote came from. I cannot tell you the substance of our talk, but that quote was in none of the papers and in none of the discussions at JECFA. I am very concerned about that whole process.
Senator Spivak: In reading one of the letters, I believe from the General Accounting Office to the Health secretary, a very interesting fact struck me. Only four of the 85 drugs used on animals are tested for residues. Then I read this reference to stringent, scientifically based programs, and I wonder then how only four of the 85 drugs could be tested for residues. Why is that?
Mr. Hansen: That was in the past. Its function changed, but, formerly, there was a required legal "tolerance," which meant you needed all the toxicology and a method for testing. Here there was massive, functionally illegal use, that being extra-label use. They were using all these other drugs that they did not have tests for. At the time they were using a test which basically picks up penicillin.
Farmers knew they could use other drugs. In fact, we had farmers telling us two and three years ago that there was an antibiotic available, pitched by drug companies as being undetectable on any of the screens.
The Clinton administration legalized extra-label usage, even though a number of us thought that it was illegal. That is now functionally legal.
There are still problems with milk testing. I was in court in New Hampshire a few years ago when a farmer who was testifying let slip that he was actually using gentamicin, which is technically illegal. He was never caught and no one ever seized his milk product.
The residue testing procedure does leave a lot to be desired. That is why they asked for the real data, being the levels in the milk from treated and untreated cows.
Even at the 1993 veterinary medicine advisory committee meeting, Dr. Kessler asked that point-blank question of Monsanto: "Did you take that data"? They said no.
That is what needs to be done. I do not understand why the PAMP did not look at antibiotic residues in the milk from treated and untreated animals.
The Chairman: As a supplementary to Senator Whelan's question, it was reported here in Canada that consumption of milk was down 15 per cent in the U.S.
Mr. Pollina: We are not aware of that.
The Chairman: It was reported here.
Mr. Hansen: I do know that there have been declines in milk consumption over the years. I do not have the figures, but the question triggers another comment. In New York, where supposedly 50 per cent of the cows were being treated, the actual milk production figures for 1994-1995 compared to 1992-1993 went down. If 50 per cent of the cows are being treated, why is the production going down and not up?
Mr. Pollina: There has been a big increase in sales of milk that is marketed as hormone-free, or organic, or somehow naturally produced. Consumers are moving towards milk products in which they have more confidence.
One of the reasons for these hearings relates to concern about public confidence in an area like health and drug safety and protection. We have had occasions in this country to have that confidence shaken somewhat. Part of the reason for having hearings like this is to ensure that our government and the people of the country will be alive to these problems and try to correct them.
In the course of the hearings, this concern obviously has broadened widely because we live close to a very successful and powerful friend, the United States. We live in an international community that has bodies such as you have talked about today, Codex and JECFA. They are supposed to be giving us guidelines on how to do the right thing. When I listen to you today, as well as to many of our other witnesses, doing the right thing is not what any of this testimony is about.
My question is: How do you get it stopped? If long-term drug testing has been conducted by the FDA in the United States, then that obviously has some kind of a psychological impact on Canada. It certainly does not govern our activities, but one watches it closely. There have been 10 years of drug testing, with all of this coming to light. It is not just people in the United States. We have heard from people from Britain and other countries. How do you get it stopped? How do you get an FDA decision reversed or at least a moratorium on this hormone? How do you do that in the United States?
Our government has now said that it is certainly holding off beyond the international discussions of next June, but it has also said that it is not going to approve this hormone until they are absolutely certain that the kinds of things that we are hearing today are not substantiated. What do you do with the FDA?
Mr. Pollina: What you are doing is a beginning. What you are doing here today and what you have been doing over the last couple of months is perhaps the beginning of that process. I think in the U.S. there has been a very close relationship between the FDA and the companies they are supposed to regulate, that the power of corporations, both financial and political power, has become so strong that many agencies have begun to abrogate their own responsibility.
We have also seen the supposed demand to get these products on the market as soon as possible, particularly in this case when there is no reason to put the product on the market. Someone eventually has to say that it is time to stop. When we make a decision we must ensure that we are on the side of safety and not on the side of corporate profits, which is essentially what has been going on.
In the U.S., relative to the FDA, there is a process. There is a petition process, whereby individuals, organizations, and policy makers can petition the FDA in an official capacity. They can ask them to revoke the application to license the product if, in fact, new information has come to light showing that either the product was not adequately proven safe to begin with or that there is now new information that brings into question that decision. We will embark on that kind of process. That is one way that we can try to get the FDA to change its mind. It is not easy, but it is not impossible. It has happened at times in the past. There really needs to be a concerted effort to make that happen. We are hoping to generate that effort in the U.S. and use whatever support we can generate from Canada to try to make that happen.
There are legal avenues available if that petition is rejected. The first step in the process is the petitioning process of the FDA.
Senator Fairbairn: Does the Secretary of Health and Human Services in the United States not have a role to play in this?
Mr. Pollina: The Secretary of Health and Human Services has a very direct role to play in this because the FDA is part of that larger agency. We have had meetings with that person in the past. That person is beginning to hear from policy-makers and the U.S. Congress, and there will be discussion and pressure put to bear on that individual to try to make the FDA either change this decision or adequately respond to the concerns that are raised in the gaps report.
I have worked on this for the last 10 years. We have seen bits and pieces and we have had our suspicions and concerns. It seems that every year or so a new series of questions is raised that keeps this issue alive. The gaps analysis may, in fact, be the most important piece of information that has come to light in recent years and could be the basis for that petition process and the change in decision making at the FDA.
Consumers are increasingly concerned about the quality of the food that they eat.
Senator Fairbairn: They are also more informed.
Mr. Pollina: They are informed, as well, you are right, about chemicals and hormones and all other ways of adulterating food. The FDA says that no significant difference has been found between the milk of cows injected with rBST and the milk of cows not injected. The question is, what is the difference and how significant is it? Based on other things that we have uncovered, we would argue that the difference is significant. There is a residue of synthetic hormone in the milk. There are higher levels of IGF-1 in the milk. There is the potential for more antibiotic residue in the milk. Those are significant differences that the FDA needs to understand that consumers are concerned about.
The petition process and the mounting of international opposition are the next steps. Keep in mind that the European community, Australia, New Zealand, Canada and other major dairy-producing nations have not approved the product and, essentially, have no intention of approving the product.
Mr. Hansen: I should like to add to that. It is a long process. You have to work at the scientific level and also generate public interest. We should say that yes, the product is on the market, but from the Freedom of Information Act material that was acquired in late 1989 or early 1990, it looked like they had planned to have this on the market in January of 1990. It was delayed for three years in part because of concerns that folks like Consumers Union were raising. Sometimes the U.S. is very recalcitrant, but at least you can talk to others in the international community and continue to fight here. That is why, through Consumers International, we have been lobbying and giving information to the Europeans and groups in Australia and all over the world working on this. In part, that is also why in 1997 it was decided to send this stuff back to the scientific expert committees. That is a result of the work and lobbying done by folks like those at Consumers International. I try to work, if I can, both in the U.S. and at the international level so that we can get to the bottom of this and try to get all of the data on this product. This product is not really needed; perhaps we can get it off the market.
Mr. Pollina: You might be aware that when we released the gaps analysis in the U.S., a reporter from our state talked to Monsanto and the FDA. Referring to the 90-day rat study, the Monsanto representative said that the data had all been reviewed by the FDA and had been approved. The FDA responded that that was not the case at all and that, other than a summary of the 90-day rat study, they had not seen that data.
That implies a number of things. For some reason, their stories are not the same this time. Since they usually are, they must be getting a little confused. It also implies that the FDA may have approved the drug without looking at the single most important human safety study, or that they may have seen the data and now are choosing to say that they never saw them. That tells me that Monsanto was in a position to cover up important information and that the FDA, whether through ignorance or on purpose, is willing to make Monsanto's position their own and allow the product to go on the market without adequately reviewing tests that they have cited.
They have talked about this test. They have discussed it. They have written memos about how important this 90-day study is and yet in October they said publicly that they had never seen the data from the 90-day study.
Ms Nelson: Farmers also have a responsibility regarding public confidence. Ultimately, we are the ones who buy this product. Historically, we have had management tools like bulk tanks and artificial insemination, but never before have we had to compromise public health concerns to manage our farms and follow the right steps and rules and regulations.
To my way of thinking, one of the big sales pitches for the bovine growth hormone and more milk is a world that is hungry. As far as I am concerned, public health needs are not yet outweighed by a world that is hungry. Maybe that situation will arise in 25 or 30 years, but it is not the case now.
Senator Fairbairn: I have a quick comment. Canadian dairy producers have made it very clear to this committee that they are not interested in this at all. If they want to increase their production, there are other ways to do it.
In this country, we are trying to get to the bottom of this before it ever reaches the point that you are at in the United States. I must say that your testimony, like that of others before you, does not give Canadians a great deal of comfort in those international organizations. They are hugely dominated in their membership by the United States and the people with the connections you were talking about. Leaving the scientific part aside, any report that gets put on to Codex is coming from a nationally skewed group. In this world we do pay attention to international associations, but given that this one is chock full of Americans and the people you referred to today, I have great concerns about basing serious conclusions and public policy on their influence. No slight whatsoever is intended by that comment, but we always talk about a level playing field, a fair chance. The rest of the players in this international grouping do not seem to have that kind of representation. That greatly concerns me.
Mr. Pollina: The international panels are an attempt to remove decision making from not just the local, or in your case, the provincial level but from the national level as well. More of those kinds of decisions will be removed from elected officials or appointed officials and put in the hands of international panels that are responsible to no one but themselves. I think your concerns are quite valid.
I wanted to mention the dairy farmers. In the United States, we are told that if you do not use rBST, you should label your milk as such. There is a niche for that product. A farmer who has never used hormones, who produces milk in the same way that farmers have done for hundreds of years, is now all of a sudden producing a niche product for which consumers pay more. It is wrong to turn a regular, basic commodity into a niche product. The rBST-free milk is sold in health food stores and purchased by people with more money, while the rest of the population buys whatever it is they have to buy. We are very much opposed to the fact that rBST-free milk is somehow a niche product.
Senator Fairbairn: That turns the whole question of public confidence right on its ear. It is crazy.
Mr. Pollina: Vermont farmers have said that they do not want to use the product. Surveys of consumers done a year or more after the product was on the market show that the great majority of consumers do not want the product.
Mr. Hansen: Eighty-four per cent want it labelled.
The Chairman: I have a question regarding balance. We have heard scientists on both sides of the issue. From what I have heard, I have the impression that there is no black or white in scientific research. There are grey areas. In this case, Canada has been very careful not to license the product because Health Canada is not confident that the drug is safe. How do you reach a balance?
I am a farmer. As we look to the future, many of those issues, how we feed the world, how we produce food and so on, will come forward. As a layman, I cannot tell you, but the scientists have a major responsibility.
Mr. Hansen: I should like to answer that because it is a very important question. I think that all of the data should be released. In fact, the studies should be done by independent scientists in the first place so that everything is open and above board. With the mastitis case, Cornell scientists and other people said that there were no health effects whatsoever. Then when they released the data in the Freedom of Information summary, we found out that there was an 89 per cent increase. To this day, I do not understand why in the U.S. health and safety data are considered to be confidential business information. Release all of the data and allow it to be looked at by scientists so that it can be discussed and argued. In fact, when the somatic cell count data were sent over to Drs. Millstone and Bruner, they tried to stop them from publishing them.
Science must work in an open process. That means that there should be an open process for designing the experiments and they should be watched very carefully, but not by people who are being paid directly by the company. All of that research has to be made available to the public. For some of us who are critics, the big problem has been that there is very little data in the published literature because the company gets to control what is published.
I think all the health and safety data that are submitted to the agencies should be made public. If they had been, we would not necessarily be having this discussion right now. We would have known back in 1990 that there were questions about that 90-day study, and they could have been asked to do a two-year carcinogenicity study and a three-generation rat study. Why does it take some scientists in Canada getting heat for mentioning that? I had heard rumours for years, but I could never say anything publicly because, unless you have proof, you cannot go public with that. All the data have to be made available and looked at by independent scientists.
Mr. Pollina: As a non-scientist, I would say that you are on the side of safety, particularly when you are talking about a production drug. If this drug were going to cure AIDS or cure a headache, for that matter, you would be willing to suffer side effects. You take your allergy medicine, you get drowsy, and that is okay. There is a reason for the side effect. However, in the case of a production drug, there is no reason for there to be any risk to anyone, the cow or the consumer, because there are no benefits.
We are not going to feed the world with this drug. I guarantee you that. These are the same folks that brought us the "Green Revolution." We have many fewer farmers now than we did 20 or 30 years ago. We have more people going to bed hungry than ever before in the history of the world, so I do not think that this is about feeding the world.
You should be aware that not only the data are secret, but the whole process is being kept secret for the most part. I have press clips about spies being sent to meetings of people discussing the issue. The process has been corrupted right from the beginning.
The people who are proud of the Canadian dairy supply management program should realize that Monsanto was one of the companies that led the effort to oppose the supply management program in the United States. They spent a lot of money lobbying against any dairy supply management program. They want farmers on a treadmill, always producing, because that makes them better customers for drugs that are meant to enhance production.
Senator Robichaud: In your presentation, Mr. Pollina, you said that U.S. law says that the FDA must reconsider and revoke a company's right. Are the same people who closed their eyes to a lack of information and gave approval still there at the FDA? Will they be called upon for reconsideration here?
Mr. Pollina: I believe a few of them went on to international panels. One went back to work for Monsanto, but I think most of them are still at the FDA, yes. That is why the petition has to be coupled with a lot of political pressure to make sure that it is adequately responded to. We have not only to submit the petition to the FDA, but really elevate the issue on a more political and public level as well.
Senator Robichaud: Has that petition been initiated?
Mr. Pollina: No. It is being prepared.
Senator Robichaud: I am quite concerned. I think it would be faster to teach the cows how to speak for themselves.
Mr. Pollina: They say "ouch" pretty well sometimes.
Senator Robichaud: Our officials have told us that there is a lack of data. You have told us the same thing, but you have also told us that there are data that have not been looked at properly. You said that there should be independent research. A lot is said but not too much is being done except in hearings such as this. Is it not the case here that time is on the side of Monsanto? That is quite important.
Mr. Pollina: I am not sure if it is or not. You could be right. There is another side to the issue, which is that I think support for their product is eroding. They have found that a number of farmers, not just in the U.S., who have tried the drug have chosen not to continue to use it for a variety of health reasons or because it was not financially beneficial to them. There is a lot of opposition still in other countries around the world. I think that having it approved in other nations would work against us. Having it on hold at this point is the best that we can hope for.
I think that it might be important for some of you to get in touch with members of the United States Senate. Have this discussion with them and let them know the seriousness that this issue has taken on here in Canada. In the same way that the international panels like to do things right over your heads, maybe it is time for the members of the two senate bodies to come together to have a real discussion that is not filtered through an international panel. I would be willing to facilitate that.
Mr. Hansen: I should like to say two things. I really wish I could talk about what went on in that JECFA meeting, but I cannot.
Senator Fairbairn: We do, too.
Mr. Hansen: When you look at those panels, consider who is on them and where they come from. On the FAO side, there are many people from the U.S. Food and Drug Administration. In fact, the head of the division in FAO is an ex-U.S. FDA official. Codex is under him.
In the international arena, time might not be on their side because, in 1997, when this product went to the Codex Commission it had gone through the seven-step process. Usually, step eight is just a rubber stamp. All the committees had said that everything was fine. In fact, even the people lobbying for the European Union at the opening of that meeting said that we are going to lose this. We do not think that we will be able to stop it.
Consumers International was the only one who did a report at that meeting and argued against going to step eight. They lobbied and talked to the African delegates and all the other delegates to point out those problems. That was the first time that many of these countries had even heard that there was any kind of concern. They turned around and pushed that stuff back to the scientific committees and the U.S. screamed bloody murder and tried to say that it was just the Europeans doing that, but the vote was something like 32 to 14. There are only 14 European Union countries, so quite a number of other countries voted with them.
I predict that there will be quite a raucous session at the Codex Alimentarius Commission in June because there was no consensus on this thing, yet it was pushed through by the head of the Codex Committee on Residues of Veterinary Drugs, sent back to the commission by Steven Sundloff who is the Director of the Centre for Veterinary Medicine at the USDA. There will be quite a bit of action there. I would not be surprised if it does not get approved or has to go back some place. The two meetings in March and in June will be pivotal. I think a lot of attention will be paid there.
There is a genetically engineered product. Monsanto is actually having problems with its other genetically engineered products, which are not being accepted in Europe. In the November 18th edition of Chemical Week magazine, it was reported that they are trying to cut costs by 20 per cent and that some of the analysts there were saying that they are thinking of selling their POSILAC business. If it is such a great product and is doing so well in the U.S., why is it being reported that Monsanto is considering selling it?
Mr. Pollina: I think if the product was really a great product and farmers were clamouring for it, we would not be having this discussion, either. They have had to pull out all the stops to get the product on the market. If it were a good, safe product that was useful for farmers, there would be no need for misinformation or dishonesty of any sort. They would give us the data on what it does, and the product would go on the market. I think they are pulling out all the stops to try to get the product on to the market and keep it there. If it were doing very well, I am sure we would be reading that in The Wall Street Journal.
Your farmers are not asking you to approve it. European community farmers are not asking to have this product approved. In fact, they are doing exactly the opposite. I am sure you will hear from farmers who say the product is wonderful, that it works well for them. I do not think there is any doubt that on some farms it will increase production. Some farms will work with it. Some farmers might come in here and say that they have no problems with this product. I just urge you to keep in mind all the other farmers who are not coming here to tell you about the disasters that they have had on their farm. These were farmers in New York and Florida, who very publicly talked about the disastrous effects of the product on their cows. The Monsanto Company did not adequately respond to them, although, as part of the post-approval process, it is supposed to be keeping track of all these farmers.
I urge you to really think twice about the kinds of things that you might hear. I mentioned before that during the approval process, we constantly ran into these small studies. They would spend a couple of years doing a study on 10, 20, 30, 40, cows. If the effects were negative, it was said that the study was too small to have any significance. If you conduct enough small studies, you find the ones that work well and you pool them together. As policy makers, you are always trying to look beneath the surface. In this case, you need a big shovel because you have a lot of digging to do to get there.
Senator Chalifoux: Mr. Hansen, how are the people selected or appointed, and who appoints them to these international committees?
Mr. Hansen: At JECFA, nominations are sent to the secretariat and then the secretariat gets to make the decision as to which international experts get appointed.
Senator Chalifoux: Who appoints the secretariat?
Mr. Hansen: That is a good question. It is interesting that JECFA is not part of the UN system. Therefore, one should be looking into where their money comes from. I will just say that the decision to invite me was fought tooth and nail by you can imagine which governments and companies.
Senator Chalifoux: Ms Nelson might be able to help me on this one. The injections take place in the cow's rear end, in the top there. I heard, and I do not know how true it is, but I was told that the meat surrounding that point where the injection is cannot be used. Have you heard anything about that, the effect that those injections have on the meat of the cow?
Ms Nelson: You are talking about injection site syndrome. I cannot tell you from personal experience. All I know is that in some of the first trials that were done at the University of Vermont, specifically with Jerseys, they had an awful lot of trouble with swelling and one Jersey was not even able to stand. I know that when we first brought out our report and had a press conference, of course, they went to someone who was using the bovine growth hormone in Vermont to get a balanced story, and that farmer is no longer using the bovine growth hormone.
A farmer down the road from us was at a school meeting where one of the community citizens wanted to have only bovine growth hormone-free milk in the school supply. A farmer who uses the bovine growth hormone was there. I said something about how in the studies, there were deformed calves. He said, "Oh, sure, we have deformed calves," like it was no problem. I asked my husband if we have ever had a deformed calf on the farm. He said we might have had one over the last 30 years.
A farmer up the road about 25 miles uses it intensely and has gone from using it every 14 days to every 11 days so that it does not drop quite so radically. It holds the curve and then drops. They use it about three times a month. I would think that the cost involved would be considerably more, too. There are people who use it in Vermont but the vast majority have never wanted to touch it.
Mr. Pollina: Many researchers would argue that there were no problems and yet we know about the injection site syndrome and the mastitis. They are really trying to redefine what a healthy cow is. They are basically trying to convince all of us that as long as a cow is giving milk, it must be healthy. Farmers recognize what an unhealthy cow is. Monsanto has a very different image as to what a healthy cow is and they are redefining the approval process. They are redefining risk and manageable risk as opposed to safety. I think they are trying to redefine what a healthy cow is.
The Chairman: I would like to thank you for appearing here this morning. I would certainly like you to carry the message back to the U.S. that we in Canada think we have some of the highest health standards in the world. We believe we have very safe food. We are interested in keeping it that way. We appreciate you coming here today. You are very welcome in Canada.
Mr. Pollina: Thank you very much.
The Chairman: Honourable senators, we have before us witnesses from Health Canada. I will ask Dr. Losos to introduce the other gentlemen with him.
Dr. Joseph Losos, Assistant Deputy Minister, Health Protection Branch, Health Canada: With me are Mr. George Paterson, Director General of the Foods Directorate, and Dr. Ian Alexander, who is a drug evaluator in the Bureau of Veterinary Drugs.
Mr. Chairman, we do not have prepared statements, but we should be pleased to answer your questions.
Senator Chalifoux: My first question concerns your department's progress in the evaluation of this hormone.
Dr. Losos: We expect to receive the reports of the two expert panels that we described to you the last time we appeared before you. At that time, we introduced the chairs to you.
As I have outlined in my previous testimony, we keep our ear to the rails as far as what is going on internationally. It is a very complex and controversial situation. The previous witnesses are an attestation to the complexity of the argument. In order to work our way through this file, we have to keep an eye on everything that is going.
Senator Chalifoux: How much longer do you think it is going to take?
Dr. Losos: I am hoping it will be within weeks, senator.
Senator Spivak: I wish to make a general statement. I think that all of us here are interested in ensuring that the Health Protection Branch and the Bureau of Veterinary Drugs have the confidence of the Canadian public. I think that is our primary objective. I must say that, in some instances, you are making it a little difficult for us to pursue that objective. However, we are not going to comment about that. I am sure you share the same objective.
I have a few questions to ask you. I am concerned about the representation on the Joint Program Management Advisory Committee. I am also concerned that the department's policy may be affected by industry requests at those meetings.
We have heard a great deal about influence here. One of your policies is a variation of something that was suggested internally at Health Canada by an individual who became a registered lobbyist for Monsanto. It concerns the practice of routinely giving the names of drug reviewers to the manufacturers. I assume -- and perhaps my assumption is wrong -- that this came about because the Canadian Animal Health Institute asked for it through the joint review committee. The drug evaluators did not agree with this policy, because they did not want to be pressured. However, in the end, the department agreed to give manufacturers the names of the reviewers directly. I am wondering why you would agree to this policy or a variation of it.
As part of your answer, I would like you to explain very precisely how you view your role vis-à-vis industry. To me, there seems to be tension between the public interest and the demand or request for a manufacturer or a company to get its drugs approved quickly. When I look at this statement, the memorandum of understanding, it gives me no comfort. It seems to be directed towards processing more quickly.
In that context, I would like you to refer to this incident and give us your views on the definition of your role with industry. Please keep in mind that we also have evidence that industry is the client and not the public. The deputy minister has denied this, of course, and said that this is not the case. I am glad to hear that.
Dr. Losos: If I can address a few of those points, then I will ask Mr. Paterson to talk about the advisory committee. Certainly, the confidence of the public is of very great concern to us.
There is no denying that the Bureau of Veterinary Drugs has had some problems in the past. Two outside consultant groups have come in to try to advise us on directions. We have hired a new director. We are moving very quickly to try to address all of those recommendations and those problems because public confidence is vital to us.
It is also important to remember that, not taking into account the problems that have been going on in the bureau, we have kept our eye on safety and science. We ordered the gaps analysis, because we wanted to be sure that all of the questions were being answered.
There is tension in our role vis-à-vis industry. This is a formal relationship where we are the watchdog. They make submissions for approval of medications and therapeutics according to our standards, which are developed nationally and internationally. There is tension because our view on the horizon is for health and safety. Sometimes, we demand of them a lot more than they have submitted. It costs them money to complete the extra studies, but that is the way it is when it comes to health and safety. There is no question -- we have said this before this committee and in other fora -- the client of the Health Protection Branch is the Canadian public, and safety is number one.
Representatives do, in fact, call Mr. Paterson or me. They try to negotiate matters so that they are according to their schedules. That is not part of our business. Our business is health and safety and things will happen when they happen.
As far as our efficiencies and effectiveness is concerned, we have systems that need improvement. As any other large organization, we need to hire new disciplines and new scientists. I would like to make it clear that our relationship with industry is a formal, distant one.
Senator Spivak: You heard what Dr. Hansen said previously in response to a question about how we could make sure that this is absolutely transparent -- that we have independent scientists and all of those things. Can you give us some indication of what you plan to do to make sure that it is totally independent? That is to say, that people who are totally independent do the research, and that they are scientists who do not even have the appearance of a conflict of interest?
I do not need to suggest to you, sir, that we as a parliamentary committee have had some difficulty getting information, and that, perhaps, has shed some light on this whole process.
Dr. Losos: Certainly, transparency is an area that I personally support as Assistant Deputy Minister, and you also heard David Dodge support that during his testimony some weeks ago. Transparency is an area where we have to do a better job, particularly in health care. There are examples in other countries where the debate around a regulatory decision is much more open -- in the United States, for example.
I was in Geneva recently, and I saw a review of a number of countries that cited a lack of transparency in regulatory agencies. We are not alone in that. I can share that with the committee, if you are interested.
We certainly need to be more open, to post things on Web sites, and to give the public the information that it needs to make informed decisions. We know that. We have not been perfect in the past.
You have heard from Ian Shugart, from the transition team of the Health Protection Branch. One very big piece of strengthening the Health Protection Branch is, in fact, transparency and public consultation. We have just finished a number of these consultations across the country. That was a first pass at it. You will see a lot more of that from the Health Protection Branch.
On the objectivity, senator, we went to two organizations on animal safety and on human safety. Those two groups -- the Royal College of Physicians and Surgeons and the Canadian Veterinary Medicine Association -- are beyond reproach as far as expertise and integrity go. We asked them to strike panels, and we put the panel members through the conflict of interest review internally.
These individuals are required to make a declaration of all of their activities, and the management teams looked at them. Management went through that, as did legal services. Whenever there were issues that came up that questioned some of these, we investigated them and answered them.
Senator Spivak: You have looked at those Health Canada guidelines recently, and examined them again with regard to the people who are now on those panels?
Dr. Losos: Yes.
There was a question on the advisory committee. Did you want us to answer that?
Senator Spivak: Yes.
Mr. Paterson: I think what you are referring to is the Joint Program Management Advisory committee.
Cost recovery was introduced into the veterinary drugs program in April, 1996. There was a meeting of all stakeholders in February of that year. At that meeting, it was agreed that we should have some kind of forum that would allow the department, industry, and the Canadian Veterinary Medical Association -- as the professional body that regulates the veterinary profession in Canada -- to come together. In that forum, they could meet and share and discuss issues of common interest and importance to the veterinary drugs program.
The Joint Program Management Advisory Committee was the outcome of that agreement. It consists of the Bureau of Veterinary Drugs, myself as Director General, the Director of the Bureau, the Chief of the Human Safety Division, and the Chief of the Pharmaceutical Assessment Division of the Bureau of Veterinary Drugs. It also includes representation from the Canadian Veterinary Medical Association, as I have indicated, and CAHI, which is the acronym we use for the Canadian Animal Health Industry. That is the industry association that represents the animal drug manufacturers in Canada.
That committee has met 11 times since April 1996, and has included evaluators from the Bureau of Veterinary Drugs as a regular part of its business. I would like to emphasize that, because I think in earlier testimony there has been some indication that this is a management body that brings together senior industry management and management of the Bureau of Veterinary Drugs, that it is not operating in a transparent fashion, and that it is somewhat nefarious. I would like to put on the record that that is entirely untrue.
I have given you the raison d'être for the committee. I have given you the membership, and I have indicated that evaluators have attended many meetings over the last two years, and I will table that with you. I will not talk about it now, because we are pressed for time. I do have records of the evaluators from the Bureau of Veterinary Drugs who have attended meetings, and the reasons they attended them. If I could leave that with you, that would be part of the record.
Senator Hays: What is the difference, if any, between testing for a drug or hormone which is intended to be used for therapeutic use, and one such as BST, which will have general usage?
Dr. Losos: Let me take the first pass at answering that question. I will then ask Dr. Alexander to continue that.
There is a very large difference between the therapeutic products that are meant for human beings, for example, and veterinary drugs. One area I would point out for you would be conditional notices of compliance. On the human therapeutic side, we do have a policy on conditional notices of compliance where, if the condition is life-threatening or very debilitating, like Lou Gehrig's disease, the company can -- under quite a strict arrangement -- apply for conditional notices of compliance. That does not apply to veterinary products, and, in particular, would not apply to something like rBST.
Mr. Ian Alexander, Drug Evaluator, Bureau of Veterinary Drugs, Health Canada: The review process involves several areas: manufacturing, human safety, animal safety and efficacy. In general, requirements for a drug are similar, whether they are for a therapeutic drug or a production drug. In other words, you have to make sure that that product will be safe. We want to make sure that the standards of manufacturing will be met -- that the product is stable, potent, and will meet the standard requirements.
As far as human safety, the requirements for a production drug and a therapeutic drug would be the same if it were to be used in a food-producing animal. There are individual variances, depending on the type of product. My area of specialty is animal safety and efficacy. For a production drug, obviously, you must determine that the product is going to meet the claims made on the label, but that would not vary for a therapeutic product. The product must meet the claims on the label, as well as be safe for use in both animals and human beings.
Senator Hays: To my understanding then, there is a different set of rules, protocol or whatever, depending on whether it is for animal use or human use. That is something that would be clear to an expert, but I am not expert. You would have these different processes and different procedures in determining whether or not a product should be approved for use.
Dr. Losos: On the human side, senator, there are extra mechanisms for extremely dangerous or debilitating diseases such as AIDS and ALS. Under very strict arrangements, a company can get a conditional license to make that drug available to physicians, but they are still required to carry out more clinical trials. At the conditional licence stage, there is already a weight of evidence that this is safe and is likely to be effective. Therefore, we allow, in very controlled circumstances, the drug to be licensed.
There is also a special access program in therapeutics for people in life-threatening situations. If a drug is not available in Canada, and has not yet been licensed, anyone can access these medications within 24 hours through the special access program. Therefore, there are special provisions on the human therapeutic side.
Senator Hays: Senator Whelan could not be here today, and he left me some questions to put to you. One of them has to do with Dr. Haydon's testimony about being pressured to issue a conditional notice of compliance for rBST. He would like your comment on that. I think you have touched on it in your response to my question; this is not done with respect to these kinds of products. In any event, I am asking this question on Senator Whelan's behalf, and he would like a clarification or a further comment on that. You can tell us what happened in the context of what Dr. Haydon had said, the issue of conditional notice, and how Dr. Alexander handled that.
Dr. Losos: Thank you, senator. The criteria for the conditional notice of compliance do not exist in the Bureau of Veterinary Drugs. I will ask Mr. Paterson to give you some more details.
Mr. Paterson: I think the situation you are referring to occurred in 1994. Dr. Haydon met with her chief, Dr. Drennan and the new bureau director at that time, Dr. Len Ritter. Dr. Ritter had come from the pest management regulatory area, an area in the department where conditional notices of compliance were used.
As part of a brainstorming session, he raised the notion that could this be looked at in terms of rBST. It was followed up, and investigated with regulatory affairs specialists. As Dr. Losos has indicated, it was determined that this was not a viable option in the Bureau of Veterinary Drugs program, and it was never carried out. It was never investigated any further, and the matter was dropped at that time.
Does that answer your question, senator?
Senator Hays: I do not know whether or not it would be sufficient for Senator Whelan, but I will leave it at that.
Another question I have is on the issue touched on by Senator Spivak, and your response to her in terms of transparency of the process. Dr. Michael Hansen recommended that test data be made public and released, and said that we would avoid problems in future and get better results if that process were followed. I would like your comment on your practice of releasing data, and your comment on Dr. Hansen's suggestion.
Dr. Losos: That is a very important question, senator. Certainly, the department acknowledges that the Senate has access to all of our information. Whatever has gone on in the past, you do have access to the information. We are bound by the Access to Information Act and the Privacy Act, however.
We would welcome working with the Senate, and we would like to work out an arrangement that is acceptable to you on the proprietary information that we are not able to release publicly. You may want to look at our reports in camera. You may want to get them confidentially -- whatever you feel is sufficient for your purposes.
Certainly, we in the department are not at liberty to release some of this information publicly at this point in time. We are looking at a review of the legislation with public consultations, however, and perhaps that will change in the future. Parliament has told us that, under the Access to Information Act and the Privacy Act, certain things must happen, and we must abide by that.
Senator Hays: I suppose some things are proprietary, and that would present a problem. Dr. Hansen goes beyond your answer, and says that the Consumers Union -- or anyone else who want that information -- should be able to get it, in order to do an analysis and make a comment. I gather that does not happen. Your further comment on that more ambitious objective, which he feels would produce a good result, would be appreciated.
Dr. Losos: Proprietary information was, in fact, what I was alluding to and that is, of course, a double-edged sword for us. We would certainly like to get as much information as we can to the public. On the other hand, the companies submit information to us under Canada's agreements and regulations. If we compromise them, we may find, as I believe Mr. Dodge commented at the last hearing, that companies are reluctant to submit applications in Canada.
In human therapeutics in particular, that may in fact compromise ill individuals' access to medications in Canada. Therefore, there really is a double-edged sword. We would like to work our way through it. There is no denying that this Senate committee has full access to our information. I would certainly be open to working with you to make that happen in an optimum fashion.
Senator Spivak: I hate to contradict you, but it is my understanding that the Access to Information Act does not apply to the Senate committee. Further, under the Access to Information Act, the minister can override proprietary information on the basis of public interest. My understanding is that proprietary information is not at issue here.
Dr. Losos: I agree with you. The Senate does, in fact, have access to anything that it needs. I am asking that we work out some mechanism whereby the proprietary information is managed in whatever way you deem fit.
Senator Spivak: The minister can override that at any time.
Dr. Losos: Yes; if there is a health and safety issue, and if the evidence outweighs that.
Senator Hays: The issue concerns the independence of expert panels and, for that matter, a whole series of organizations that are involved in commenting on, reviewing, approving or not approving the use of a substance or product -- such as a drug or hormone. We have heard a lot about the fact that the same people appear in various capacities in the industry, in the government, and in different areas.
Without getting into any detail, it is causing concern among some members of the public. What do we do about that? Are we short of people? Is that why we see so many people with similar backgrounds, which suggest in some people's minds that they are acting in conflict? Is this a science that does not have a lot of people, and therefore extraordinary steps must be taken to ensure that these questions do not come up?
Dr. Losos: It is very common for researchers, certainly the best researchers, to do contract work with companies. I do not know of any researcher of any stature in Canada who does not do clinical trials or research under contract with companies.
The other side of the equation is that, at that level, people reach an eminence and an integrity that is very desirable for us as far as expert opinions on any particular regulatory or public health matter. Therefore, we build firewalls. Those firewalls include such things as a requirement for a declaration of conflict of interest and a detailed examination of it.
Anyone without a clean bill of health, if you will, for conflict of interest would not be considered. It would be very difficult, however, for us to find anyone nationally or internationally who does not do some work with a variety of organizations -- private industry, medical research councils or whatever -- as far as research is concerned.
Senator Hays: One of the things you are really relying on is disclosure, so that, if people are filling more than one role, at least everybody knows about it. That certainly seems to be the case here. I do not know whether it was easy or difficult for them to find that out but, in any event, we have received a great deal of testimony both today and previously that these overlaps do occur. Is there a specific criterion you use to determine when it is okay to use someone who has a background that might give rise to this question? Where would you draw the line?
Dr. Losos: We look at each individual case in order to see what the relationship was, if any, how close it was, and when and how it occurred.
One mechanism that we use is to go to organizations with expertise and integrity. In this case, we went to the Canadian Veterinary Medical Association and the Royal College of Physicians and Surgeons. I can think of no one in Canada with more eminence and integrity than those two bodies. The Royal College of Physicians and Surgeons, for example, licenses every specialist in the country. They take care of everything from those being born to those dying. I cannot think of an organization that has more integrity than that.
We relied on those organizations to find people of eminence and expertise. We then put those people through the firewalls, as I called them, and found a number of people that we think are eminently qualified to give us their advice on both animal and human science.
Senator Hays: One of Senator Whelan's questions deals with that, in terms of a member of the Canadian Animal Health Institute serving on one of the expert panels. You may know more about this than I do. In any event, that is supposedly a specific example of this. Could you comment on that?
Dr. Losos: Mr. Chairman, the policy coordinator who is managing the relationship of the branch with those two agencies -- the Royal College and the Veterinary Medical Association -- is in the audience. He would know some detail on that specific point. With your indulgence, I will bring him to the table.
The Chairman: That is fine. Please proceed.
Mr. Joel Weiner, Acting Director General, Policy Planning and Coordination Directory, Health Canada: Honourable senators, with respect to the senator's question, this deals with an organization that Dr. Paterson referred to earlier in his testimony, the Canadian Animal Health Institute. An allegation seems to have been made that one of the members of the expert panel on animal health, in fact, the chairman, Dr. Ian Dohoo, is a member of that organization. This is a question that came up in the Council of Canadians' news conference last week. It was drawn to our attention. I personally, in collaboration with Dr. Paterson, undertook to find out what the situation was.
I can report that we have had a letter from Dr. Dohoo himself. Last week, we made that letter available to the media, with Dr. Dohoo's express permission. Dr. Dohoo himself had been approached by the media and he made the same letter available to those reporters who contacted him. I think it would be in order, Mr. Chairman, to table Dr. Dohoo's letter with you.
Dr. Dohoo is the Associate Dean of Graduate Studies and Research at the Atlantic Veterinary College, which is part of the University of Prince Edward Island. When the Atlantic Veterinary College was established in the early 1990s, it determined that, as a university policy, it behooved the organization to affiliate itself with CAHI, the Canadian Animal Health Institute, in order to bring to the attention of industry and other academic institutions the fact that the Atlantic Veterinary College was up and running, that it had qualified staff and had the capabilities to do clinical studies. We have been told that it was for that express purpose that the University of Prince Edward Island Atlantic Veterinary College decided to take out an associate membership in CAHI.
For a number of years, the university designated one or two officials to be the point of contact between CAHI and the Atlantic Veterinary College. What we have been told is that it was simply a question of convenience, being able to post in directories the names and addresses of the responsible or designated members of the Atlantic Veterinary College so that requests for information about research capabilities, or perhaps suggestions for clinical trials, could be forwarded.
I will have to check letter we have from Dr. Dohoo, but I believe he was appointed Associate Dean of Graduate Studies and Research in 1996. In that capacity, he became one of the two designated officials. He has told us that he was not active in the organization. He did not personally have membership in the organization. The institution of which he was an employee did have an associate membership, for the reasons that I have outlined, but apparently last year that relationship was not continued. In fact, the Atlantic Veterinary College of the University of Prince Edward Island terminated its associate membership in CAHI.
I would be pleased to table Dr. Dohoo's letter.
Senator Hays: I think it would be helpful to have the letter. Mr. Chairman, that concludes my questions.
The Chairman: I have two questions. When the dairy producers of Quebec appeared before the committee, they indicated very clearly, if I understood them correctly, that there are other ways of increasing their production that they would use if that became necessary, other than using the drug. I think that is what I heard from the Dairy Producers of Quebec.
If Health Canada were to receive information that this drug was without a doubt scientifically usable, how would you deal with the situation? Have you had meetings with the dairy producers or is that strictly political? How do you deal with this kind of situation? This may be a hypothetical question, yet it is, I think, quite real.
Mr. Paterson: I agree with you, Senator Gustafson, that it is a very real question. I think both at the June meeting, when I appeared, and on October 29, when I was asked to answer a question on interdepartmental linkages, I fully briefed you on the fact that,while Health Canada has the ultimate responsibility under the Food and Drug Act of determining whether this product will be safe for use in Canada, there are other players in the federal government who are involved. I think I outlined that quite clearly and comprehensively to you.
In the same way, not hypothetically but in reality, we have had a continuing dialogue with industry groups. CAHI is obviously one that has a very close interest, and the Monsanto company is a petitioner. We have also had discussions with the Dairy Farmers of Canada, the National Dairy Council, the Food and Consumer Products Manufacturers and the Canadian Council of Grocery Distributors.
While from our point of view, health and safety is the pre-eminent criterion on which we will make our decision, we have not, I think, been doing this in isolation from other factors, either internally within government or externally with other stakeholders. We should not forget that the Consumers Association of Canada has also been part of these periodic but regular interactions with other stakeholder groups.
The Chairman: I guess the basis of my question is that I happen to believe as a farmer that there are many things coming down the pipe, and on many of these issues I would honestly say that I would side with Monsanto, because I know of many good products that they brought on scientifically that have helped us on our farms.
Senator Robichaud: Do you have all the data?
The Chairman: I do not, but I am affected. What I want to say here is that we had Mr. Gifford on trade before us. He indicated that, for instance, the Europeans are not buying any canola from us for certain reasons. I am a canola producer. That affects me. I want to be sure that I have adequate ability to trade into the international market on a very safe basis. As a canola producer, I may come down on the other side of that issue, because an awful lot of good has been done in terms of genetics in canola production. I think it has been an outstanding success. How we deal with the political aspects of it will become more important than ever, as new scientific development emerges, in order to get the best for Canadians and yet have a very safe approach.
Mr. Losos: If I may comment on that, certainly, from the branch perspective, life is pretty clear. It is health and safety. The other factors that you were alluding to are in fact going on in international debates. The Codex committee described by the previous witnesses is in fact having a meeting next spring at which these other factors will be brought in. They will see if they can come up with some kind of game plan, if you will.
The Health Protection Branch, in looking at legislation and looking at public involvement and transparency, will itself be looking at these aspects. That is why we are hoping that the Canadian public, as it did in the first round of consultations, will continue to take part in these and help us redesign and strengthen these programs. There are discussions and concepts being debated around the world. I do not think anyone has the end point in view at this time.
Senator Fairbairn: Dr. Losos, you mentioned at the very beginning of your comments this morning that the gaps analysis was ordered by the government, by the health department. I simply want to make the point that it should be commended for doing that. Also, the scientists who did the gaps analysis did a pretty good job; the basis of this work, from what we heard this morning, has become of interest and help outside our borders and that is good. In the last few days, the department has made it clear that the two expert panels on human safety and animal safety are about to report in the next few weeks, perhaps even before Christmas. Maybe you could give us a more precise notion of exactly the angle that they will report on.
However, the government has gone beyond that now. In addition to some of the comments that have been made here about the need to get back to the basics in some of the scientific evaluation, which was very much the notion expressed here earlier this morning, we have gone beyond that and we are going to wait now to hear what comes out of the Codex Alimentarius meeting next June.
What is Canada's involvement in Codex? What is Canada's involvement in JECFA? You have two Canadian expert panels. We want to hear from the Codex people, and that is fine, but what weight is put on the decisions of that particular group? You have heard from scientists, you have heard from farmers, you have heard from citizens, you have even heard from senators. There is just a tremendous amount of concern on this.
As Senator Gustafson said, it goes beyond one case. We are in a world now where new issues are coming up more and more frequently. All of a sudden, maybe where it is least expected, you are faced with something called rBST. Maybe it is because cows are involved, but rBST has caused enough concern among the public that they are asking searching questions. They are doing so at a time when there can be an explosion of other issues in genetic engineering; so the answer that comes out on rBST has a weighted importance that maybe even three or four years ago it would not have had.
What is the significance of the Codex for us? Are we, in the final analysis, coming back home and making our decision based on "made in Canada"?
Mr. Losos: These really are important questions, both for this Senate committee and for the public at large. We have been on record with this committee and elsewhere as saying that we would not make this health and safety decision just based on one review.
We have excellent internal experts, as you have alluded to, and I will use this opportunity as a sidebar, if you will, to say that the branch is really blessed with a huge number of very dedicated, excellent world-class scientists. I am proud to lead them.
However, we do not rely, especially on complex issues, on one source of information. Therefore, using expert panels as well is a fairly common activity. Even there, we would not rely on one recommendation or one set of recommendations from those panels. We will keep our weather eye out on what is happening internationally. The Europeans say they have new data that they want to present. We want to hear the data before we make any decisions.
I will ask Dr. Paterson to explain the mechanics of how we relate to JECFA and Codex.
Mr. Paterson: The Codex Alimentarius Commission is an international food standard-setting body that was set up under the aegis of the World Health Organization in its food and agricultural organization. Over 150 countries participate in Codex. Canada, obviously is one. There is a series of what I would call expert committees feeding into the main Codex Alimentarius Commission. I will give you a few examples that were mentioned in earlier testimony: the Codex Committee on Residues of Veterinary Drugs in Food; the Codex Committee on Food and Labelling; the Codex Committee on Fats and Oils. These are what I would call expert committees that, within their sphere of expertise, look after the standards, guidelines, and recommendations that, after an eight-step process, would go to the main Codex Alimentarius Commission for ratification.
As Dr. Hansen indicated with respect to rBST, the Codex Committee on Residues of Veterinary Drugs and Food approved step eight, that rBST should have basically no maximum residue level. That went to the 1997 full Codex Alimentarius Commission, where, after quite a bit of debate, it was referred back to JECFA. I will come to JECFA in a minute.
The Codex Alimentarius Commission meets every two years. The next meeting is in June 1999 in Rome.
If there are any supplementary questions, I would be pleased to answer them, but, in a nutshell, I think that is the Codex Alimentarius Commission.
There is one thing I should mention on the domestic front. This year the Government of Canada has launched a review of our role in Codex. We have a discussion paper out; we have had feedback on it, and I would be more than delighted to share that information with the committee. We would also find it particularly beneficial to get your input as we determine our strategic involvement with Codex as we go into the twenty-first century.
Another point I would like to make is that the lead role for the Codex Alimentarius Commission, because primarily it deals with health and safety, is Health Canada. In other words, the secretariat for Canada is provided through Health Canada.
JECFA came up earlier. JECFA is an independent body. I think Dr. McLean, when he was here on October 29, and Dr. Hansen today confirmed its independence. They then had different views, of course, on its effectiveness, but JECFA is independent of the Codex Alimentarius Commission. Again, though, it is, it relies on its funding from the two parent organizations, the Food and Agricultural Organization and the World Health Organization. It has a small secretariat just to keep the machinery going. I think it turns over every five years, but I would have to confirm that. If that is important, I will. It puts together various expert panels to look at food additives that are coming through. Food additives also includes veterinary drugs.
Dr. Ritter, I would just like to address that because that came up in the earlier testimony. Dr. Ritter was involved in the 1992 JECFA evaluation of rBST and he was involved in 1998 but only as a temporary scientific advisor, like Dr. Hansen. He was not a permanent member like Dr. McLean who appeared before you on the 29th and, like Dr. Hansen, he had no voting rights.
I have been somewhat brief just in the interests of time but if there are any supplementary questions on either Codex or JECFA, I would be pleased to address them.
Senator Fairbairn: On that point, Dr. Paterson, I think some of you were listening to the discussion that took place before you came to the table. I think there is a genuine concern that these bodies are dominated, even maybe more than dominated, by one source: the FDA in the United States. As we assess our position or our association with them, I think this must be of concern that on issues like this we do not speak with one voice necessarily in North America. We have private national views on these things. Certainly, the whole reason for even having this discussion is because of the concern and the controversy that this has raised. That is in my mind anyhow, a question of the relevance, the relevance to us ultimately of the guidelines that come out of them.
We are talking, and should be, about health and public safety. It is hard to sit through these hearings without also hearing about health and animal safety. We have heard anecdotal evidence. We heard some of it this morning from Ms Nelson. We will be hearing more this afternoon from people, not in Canada because once again we have not approved this hormone and it is not used, but from those who have. Some of the anecdotal stories that we get are really quite disturbing and horrendous. I would ask Dr. Alexander perhaps because of his position with animal health and efficacy, surely this must be part of our equation. It is really a question of not just interest but concern that this is not a therapeutic drug. This is not a laboratory that is producing something that may cure cancer or whatever. This is a production drug, a production hormone that is being used. It is distressing and hurtful and causing unfortunate difficulties for the animals in which it is being used. This surely must be of concern to us as well.
Mr. Alexander: Yes, you are right, that is certainly part of the evaluation process is determining what potential safety factors could be involved with the drug, as well as looking at the efficacy side of things. There is a worldwide body of evidence concerning rBST that we have had to review and are continuing to review. As Dr. Losos mentioned earlier, the panels are expected to report shortly. I recognize that various bits and pieces of information have been presented at your hearings over the last few meetings that you have had. We hope that the panels will come forward with some of these recommendations as far as dealing with the risk associated with potential side effects, how significant is that risk, is it a management risk associated with potential side effects. They have made it clear to us that they are going to look at the animal welfare issues as well. We are waiting on the panels to come back.
Senator Fairbairn: We will certainly be watching that, too, because as my colleague Senator Robichaud has indicated, cows cannot talk. We certainly are concerned at some of the stories that have been related to us and in terms of risk management, which is a kind of awful phrase really when you are thinking of either health of animals or health of people, but nonetheless this surely must be a factor in our decision, too.
[Translation]
Senator Robichaud: You mentioned two reports the findings of which should be released in several weeks. Mention was also made of the need for more information. I have a hypothetical question for you. If these reports were to find that information is indeed lacking, would Health Canada be prepared to initiate studies to obtain that information?
[English]
Mr. Losos: Senator, if we were not convinced that the data could be done internally, we would sometimes contract that out but we have in fact carried out internal or external studies where that was required. We would do that within our toxicology units that still remain in the foods or environmental health programs. We still have quite a capacity in the foods program itself. However, on occasion, provided they pass those fire walls that I described earlier on, we use contract research to make that happen.
If this were a significant piece of a gaps that existed in this file, we would certainly consider that.
[Translation]
Senator Robichaud: I have no doubts whatsoever about Health Canada's abilities. Their officials have clearly demonstrated to us that they do take a cautious approach. The point I wanted to make is that we must not look to the company seeking to market this hormone to get the information we need, because of the delays involved. We could be told that it might take a further six or eight months to get that information. The process is ongoing at CODEX and elsewhere and at some point, the realization will dawn that it is too late. That is the point I was trying to make.
[English]
Mr. Losos: Certainly, I understand what you are saying, senator. That is an excellent point. We will have to see what the gaps are, if there are any, and we would have to decide at that point whether we pursue them or wait for the international community to pursue them, other research in other countries perhaps. We would have to see what those gaps are. It is already true that the gaps analysis has flagged some areas our scientists internally would like to see more information on. We will have a look at what those expert panels have said as far as those gaps are concerned. I believe Dr. Mueller, in front of this Senate committee, raised some concerns. We will be looking for those expert panels to address those.
[Translation]
Senator Robichaud: How would you qualify the relationship between Health Canada and the U.S. Food and Drug Administration?
[English]
Mr. Losos: We have quite a good relationship, senator. The border being 3,000 or 5,000 kilometres long, something like that -- I still think in miles, I am afraid -- it is incumbent on us to have a lot of relationships with them when it comes to fraud or recalls that they may be involved in. We certainly share information with them on a minute-to-minute basis as to what may be going on in either country. We have perhaps not as developed but we certainly have relationships with the regulatory agencies in other countries: Mexico, United Kingdom, France, and elsewhere on all fronts. The therapeutics area, with the United Kingdom and Europe, the environmental safety programs that the Health Protection Branch works through a variety of multilateral relationships with other countries. Our relationships with the FDA and other agencies is minute-by-minute business because that is what must happen in a global world.
[Translation]
Senator Robichaud: Has Health Canada been in touch with the FDA regarding the approval process for this growth hormone and has it at least hinted that the situation was highly embarrassing?
[English]
Mr. Losos: I cannot comment on the last question, senator, but certainly, we have contact with the FDA on rBST throughout the years. We have not approved it, so we are not convinced that their approach was particularly the one to take at that particular time, but the answer to your question is yes, we have had numerous contacts with them. Have we pointed out our concerns? Dr. Patterson will elaborate on that.
Mr. Paterson: Somewhat, but I guess the answer to your last point would be no, I do not think where the review is at, that kind of detailed analysis and feedback to them is at the right point in time to be raised. We have, as Dr. Losos has indicated, an ongoing contact with them. Indeed, Mr. Weiner and myself had an hour and-a-half, two hour teleconference with the FDA last month after the October Senate hearings. Yes, we are in contact with them. I think that we must proceed with our own review in the way Dr. Losos has outlined before we would get into some of the detailed aspects that you raise.
Senator Chalifoux: It is very interesting. As a consumer with a very large extended family who are also consumers, I am concerned. In addition, I have received many calls regarding this. This drug has no therapeutic use. We do not need any increased milk production in this country. We have heard so far this morning that it is not needed in the United States either. Why is it then so important that this drug be put on the market? Is any pressure being put on by anyone regarding this drug? The bottom line is why do we as Canadians and Americans need this drug if it has no use?
Mr. Losos: I will answer your last question first. We are evaluating it because by law we have to. It is part of the Food and Drug Act that we do not have a choice as to whether we do or we do not. Parliament has given us that instruction and so we are evaluating it.
Your point about having an extended family is a good one because we all have families, too. Safety and efficacy are important to us. Certainly, it is important that safety be number one. Efficacy as was discussed in and around the animals a few minutes ago was the other side of the coin on this particular drug, but it is important to us as well.
Senator Chalifoux: Is there any pressure being put on by anyone? If so, by whom?
Senator Hays: Not by this committee, surely.
Mr. Losos: Your question, senator, as to why is it important, you might want to ask the petitioner, Monsanto, later on today. These gentlemen are free to speak for themselves. I do not believe that the pressure from Monsanto has been any different from other companies. They phone us up on one side of the equation and others phone us on the other side of the equation. That comes with the turf that we hear complaints or have pressure from a variety of sources. That does not mean that we are pressured into making a decision.
Senator Spivak: To put this thing in context, it appears to me that it is the Food and Drug Act and its regulations that is the key issue here. The Food and Drug Act makes no mention of risk management or cost recovery or any of those things. It may be does, you could correct me. As I understand it, it has a specific package for drug approval. It is true you are required to look at proving the drug that is proposed to you. I would like to explain to you some of our concerns, or my concerns, specific concerns about the manner of approval.
Dr. Yong, after two weeks, sent a letter of notice of compliance. That does not seem to me to have followed the terms of the Food and Drug Act. Then Mr. Alexander, you named Dr. Ritter to the JECFA. That is my understanding. If I am incorrect, please tell me. Of course, Monsanto was interested in having Dr. Ritter appointed.
Dr. Paterson, I would like to raise the question of dual marketing with you. This is based on memos. You were discussing a dual marketing system which would look at if rBST is approved. While that may be perfectly correct behaviour, I do not see how that conforms in spirit to the Food and Drug Act which talks about the public interest and the manner in which a drug has to be approved. I am talking about long-term studies on toxicity and so on and so forth. What I am saying to you here reflects what the public is thinking as well because the public looks at the Food and Drug Act. That is their health protection. Why are there all these committees and why are we relying on JECFA and Codex Alimentarius when we should be primarily sticking to the Food and Drug Act?
Therefore, the conduct of officials here would appear, and I am very careful about this, would appear to be sort of taking for granted on the basis of whatever that this drug should be approved and not undertaking the very intricate process which the Food and Drug Act recommends. I wonder in those two instances, Dr. Paterson and Dr. Alexander, if you could comment on your actions in this regard and comment on the general principle of where the Food and Drug Act, which is our national sovereignty, stands with regard to all of these committees which may or may not say whatever.
Mr. Paterson: I will go first. I think your point to me was about dual marketing, an internal memo or note, that I had made a comment about that. I would like to go back to the answer I gave to Mr. Chairman about are we doing this strictly in a vacuum. That may be a paraphrasing of his question. In my response I indicated no, that while health and safety and the Food and Drug Act was the main criterion that drove us in looking at this product and, indeed, any product, we have to recognize that there are other issues swirling around us. The fact that this is my third time back in four or five months is indicative of that.
Interdepartmentally, we have maintained a liaison and a coordination with agriculture and agri-food culture, with the Canadian Food Inspection Agency, with the Department of Foreign Affairs and International Trade, and with external stakeholders.
Hypothetically, and we have heard that word used several times this morning, should rBST be licensed in this country, then there would be implications that go beyond just the label indications. We have heard Dr. Chopra in his testimony say that there are many label indications that would make one question whether you would approve this drug. Going beyond just the label use, there would be implications to the production and marketing of milk and milk products in Canada. In that context, as part of our dealing with our colleagues throughout the federal government and indeed provincial governments, because provincial governments have a major role in the milk production and marketing system in Canada, we did look at the implications.
The National Dairy Council appeared before you two months ago and were very strong on this, and felt that if the drug was to be approved, there would have to be a dual marketing and this would increase the costs exorbitantly and prohibitively to the industry. It was in that context, senator, as part of a briefing note to our senior managers, we tried to capture all the other issues that were swirling around the health and safety, which is our predominant one and which is still our predominant one. Does that help?
Senator Spivak: I guess it does. I think my question would be why would we not first concentrate on the long-term studies and then worry about the other issues later? However, that delves into the internal workings of the department. I do not want to get into that, really.
Mr. Paterson: Before I turn over to Dr. Alexander, I would say that instead of doing things necessarily in a sequence, rightly or wrongly, we tried to look at some things in parallel.
Mr. Alexander: I just wanted to clarify one statement that you had made about Dr. Ritter. I am a drug evaluator, somewhat to the other scientists who appeared before you on October 27. I have not had any role in appointing anyone to JECFA.
Senator Spivak: Thank you.
Mr. Alexander: My understanding is that the appointment to JECFA is made by an invitation and, in Dr. Ritter's case, it would have been an invitation by the secretary of the WHO to participate in the JECFA process as a temporary advisor.
Senator Spivak: Thank you for clarifying that. My understanding, and perhaps it is wrong, is that Monsanto did raise that name to someone in the department or the name was raised and, in fact, then he was appointed. I am just wanting clarity on that.
Mr. Alexander: I cannot give you any clarification on that, I am sorry.
The Chairman: Monsanto will be appearing after lunch and those questions can go to Monsanto.
Senator Hays: The Health Protection Branch does have the confidence of Canadians in general terms. I remember asking Dr. Chopra or one of the witnesses who appeared at that time should we be worried about the system of approval we have for products, drugs and other products that the Health Protection Branch is responsible for. The answer I received is that our system is the best in the world. I was pleased to hear that.
In the case of this particular hormone, what seems to have happened from my perspective on this at this point is that the way in which differences amongst scientists have been resolved or not been resolved is the real issue here. Of course, scientists will naturally differ on the extent to which these tests should be done or those tests should be done. I guess, in the end, it is whether or not they think approval should be given or not given. The Health Protection Branch must have a way of going through that process and coming out at the end of it saying yes or no.
You now have a relationship with the Auditor General in terms of work he has done in the Health Protection Branch. There are some outstanding issues. I would appreciate a comment on that. Of course, the motivation for asking the question is the suggestion to us from the Dairy Farmers of Canada that the Auditor General should have a further role to play in looking into and helping resolve what appears to be some difficulty or what are some difficulties in this way in which differences among scientists are dealt with and in the end resolved.
Mr. Losos: That is an excellent question and really an important one to get on the table because the differences of opinion between scientists certainly is very common. Rarely have I seen a file where there have not been differences of opinion. In fact, I welcome that difference of opinion and that challenge of each other. I will also say that over the years that perhaps in certain units those differences of opinion between scientists were not properly coordinated or managed.
The branch does have dispute resolution mechanisms when it comes to science, but I would say that they have not been used uniformly across the branch in the past. You can rest assured they certainly will be because I personally and my senior staff will be strengthening that dispute resolution mechanism from here on in.
What we have done in the past on occasion is to pick from our expert advisory panels, for example, standing panels, of which we have quite a few, a number of outside experts and have a seminar-like presentation of the science by the varying views and then a resolution of that. It needs to be more systematically used in the branch. I am going to ensure that that happens.
The Auditor General has been looking at the branch, and looks continually at the branch on a wide variety of topics. Over the last number of years, he has looked at changed management in 1995, has looked at the food safety system in conjunction with the Canadian Food Inspection Agency, has looked at environmental health programs. There is a team within the branch right now which is looking at the capacity of the branch for being the hurricane watch, the surveillance systems and the monitoring systems for safety. They have not, in their scoping out of work, identified the Bureau of Veterinary Drugs specifically for evaluation at this particular time.
I would like to say, senator, that at the same time as the Auditor General is involved fairly well constantly with the branch because of its size and scope, that there are also other evaluation mechanisms that happen continually. Certainly, as a scientific organization, we commission a number of outside evaluations of our programs by academic centres or accreditation-like groups that will come in and look at our programs. As well, the department has an internal audit unit that systematically goes through the department and cyclically evaluates programs using outside evaluators. For example, this will be the third pass at the Laboratory Centre for Disease Control and surveillance functions that the auditor general is looking at. That will be the third pass in about eight or nine years in evaluation.
As a scientific organization, we welcome review. Nothing ever stands still. It is a good program. As Dr. Chopra said, it is world class. However, nothing stands still, and we need to move along. That is why we presented, and Ian Shugart presented, the transition programs to you last time. That will include better transparency mechanisms, better dispute resolution, peer review, a number of scientific activities in which the branch needs to be strengthened.
Senator Hays: Who are the other evaluators? Can you give me a little more detail on that? The Auditor General could be a evaluator and I guess is in a way on the things that he has expressed interest in and that you are cooperating with him on. You mentioned that is not the only thing ongoing that might be used to address the issue or problem that I described, or at least that is the way I see it. Others may differ. Who are some of these other evaluators?
Mr. Losos: There are other mechanisms, senator. The department has an internal audit unit which hires outside contractors to come in and look at the various programs within the department. Treasury Board will do reviews. The managers themselves will commission accreditation-like teams to come into a scientific unit. I have done it myself in the lab centre for Disease Control, for example, with the tuberculosis program being reviewed, the sexually transmitted disease program being reviewed, and I would commission at arms length from the scientists being evaluated, an evaluation using whatever organization, the Royal College or whatever, to come in with five or six or eight scientists and go through from top to bottom an evaluation of the science and the program effectiveness in that particular unit.
Senator Hays: Thank you.
The Chairman: I want to thank Health Canada for appearing here today. It goes without saying, and I am sure that each senator here would ratify what I am saying now, that we have received more questions, more letters, more correspondence on this issue. In fact, in my office, there is as much as on the farm crisis situation or possibly even more. There is a great deal of interest. I think it is important to note that we have very high standards in the mind of the public, as well as by Health Canada, and we appreciate that, and appreciate that that should be protected on behalf of Canadian citizens.
The committee adjourned.