MA Agriculture 34842

THE STANDING SENATE COMMITTEE ON AGRICULTURE AND FORESTRY

EVIDENCE

OTTAWA, Monday, April 26, 1999

The Standing Senate Committee on Agriculture and Forestry met this day at 9:00 a.m. to study the present state and future of agriculture in Canada (recombinant bovine growth hormone, rBST, and its effect on the human and animal health safety aspects).

 

Senator Eugene Whalen (Deputy Chairman) in the Chair.

 

The Deputy Chairman: We will proceed with our first witness, Dr. William von Meyer.

 

Dr. William Von Meyer, Individual: Honourable senators, I am from Wisconsin. I earned a Ph.D. in the School of Agriculture at Perdue University in 1964 where I was also licensed to handle radio-isotopes and conduct metabolic and chemical research.

At the end of my Ph.D. program, I joined the Roman Haas Company of Philadelphia where I was a group manager for the development of selective systemic pesticides, primarily for control of fungus pests in agronomic crops.

I spent seven years there developing selective toxins. I am the inventor of the triazol class of fungicides which were sold in wheat and replaced multiple sprays of carbamates with a season-long, one-dose, one-spray product.

I am also the co-inventor of Kason 893 biocide, which replaced mercury initially in paints, and chlorinated phenols on cottonseed. There's not much cotton in Canada, however.

Following seven years in the laboratory, I was promoted to section head of agriculture and animal health products at the Roman Haas company. All agricultural research and development conducted in 43 countries, including Canada, reported to me for Roman Haas products. I am personally responsible for the toxicology of the largest selling fungicide in the world, diathane M45 and Maneb, and for the toxicology work that was done at that time on 45 per cent of all the fruits and vegetable crops in Canada.

Coincident to my position, I was responsible for the investigations of the deaths of humans contacted by Vacor rodenticide. Vacor was a pancreatic poison -- take note of this -- that was active in man but not in baboons, a close genetic relation of man. When it was introduced, within the first 30 days of introduction, that product killed more than 20 human beings, including a number of children.

At that time, I employed to work with me and the chairman of the board a pathologist whom you may know, Dr. Frederic Readers. He was the major witness in the O. J. Simpson trial.

I have also been responsible for the study of human cancer biology and the genetic effects of food residues from the world's largest-selling fungicides, the EBDC fungicides. This review was brought about by the formation of a metabolite in the fungicides which occurred in foods of various types called ETU. I would hate to estimate what we spent studying that food residue but it was in the millions of dollars.

I was a member of the FAO/UN industry cooperation program for two years. In 1978 I joined the Martin Marietta Corporation as director of their organic chemical synthesis division. We conducted chemical research with Shell Chemical International in a joint venture trying to make safer pesticides. I spent several years and made several thousand chemicals in that program, plus in the work that I did at Roman Haas.

In 1981, I became the vice-president of the largest genetic research company in the United States, Cidas, which was subsequently divided into two or three companies when purchased by other parties interested in specific businesses.

In 1983, I founded Fairview Industries, which is an entrepreneurial firm that conducts biological chemistry and food production general genetics.

I will read through my presentation and then transmit to the chair the comments and technical papers which bear on this. I intend to win this argument about the lack of safety of this material in milk. I did not come all the way here to lose this argument. I hope someone from Monsanto is here and they can answer my questions or the questions posed by the chairman.

Toxicology research conducted by the writer over the past 25 years has shown that we tend to make mistakes as a society in the following general ways.

First, we often do not define the compositions which will contact mankind and the environment well enough to understand what might be toxic. Sometimes we do not contact test animals in the way that they will be contacted with actual usage. By testing candidate toxins for too short a period of time before they contact the public, we can create a risk just by doing that. We often do not imagine what the mode of action of a chemical substance might be before we release it to the public, as sophisticated as we think we are.

By assuming there are no secondary or metabolic effects formed as a result of the usage of the material, we delude ourselves into thinking that a process or a product is safe enough to use. We often assume that one species has the same response as all other species because of some essentially academic report, rather than an actual test on an animal in which you are interested. That is how the people were killed with Vacor rodenticide. We assumed something that was false.

Thus few studies include an immunological profile of a chemical or a biochemical or a residue or a metabolite. We almost draw a wall at the FDA and the EPA. After the toxicology is done on the parent product in the bag, we start to draw a wall. We do not want to look, because it is expensive, at all the stuff that is formed in the environment. We have been avoiding that for years and years and people avoid me because of that. I do not want them to avoid me but they do.

Considering the practical aspects of these matters, one may recall that the food additive tryptophane was fatal to humans due to the formation of a process byproduct bis-tryptophane. Boy, cover that up. If you found that on one page in the media, you would be very surprised. The FDA went over to Japan to show Odenko and were essentially turned away at the door. So much for that.

The drug candidate fialuridene was found fatal to humans in the early phases of testing. The Vacor incident which the writer examined resulted in the deaths of 20 people before the product was stopped. While we were stopping the product in the company, it may be interesting for you to know that senior financial people were pressuring the board to keep selling it. This is a problem that we have.

It was then learned that mistakes had been made in the developmental research and that the primate baboon had a different metabolism as regards its pancreas than humans. During the trials on interleukin cancer-drug candidates at my company Cidas, critical inquiry occurred in several patients such that the candidate cancer drug had to be administered in an emergency ward. That was all covered up in the media.

It is not that I am against the media but it just never reached the media, as far as I know. This information was not released to the public and the compounds were regarded in the media as promising.

In infants' foods, the monosodium glutamate compound was banned supposedly for causing hypothalamic lesions. I have not investigated that but reputable people say that was the case.

Diethylstilbesterol proved a carcinogen from dosages which, in their day, were non-detectable at 6 parts per billion.

The triatagenic or birth defects caused by ethylene thio-urea were found much later in the date of introduction of the compound which gave rise to the terratogen. These compounds are the major fungicides used in agriculture. Thus the spray-to-harvest intervals were changed on most crops by my department to accommodate no possible birth defects caused by agricultural residues.

Each generation of mankind, however, apparently must repeat to a certain extent the mistakes of the previous generation before they imprint what must be avoided to prevent environmental disasters.

(tk 0920 follows--von Meyer cont.--I see that many of you are my age or more senior and that I am glad of that because you know) 34842/Agriculture/April 26, 1999/DM

(Mr von Meyer continuing)

I see that many of you are my age or more senior, and I am glad of that because you know what I am talking about.

The writer has come here today to help prevent a probable adverse effect which could arise from the meagre and poor developmental effort conducted on BGH or BST milk. We will convince you today to either prevent the sale of BST or cause the collection of substantial data which do not now exist. This is a promise.

In closing my introductory remarks, we would say that after 25 years of research into biological processes and active materials, the first and most likely error to cause serious public risk in the release of a potentially biologically active residue or product is to omit chronic health testing.

My company started looking at recombinant bovine somatotropin in 1991. I did not intend to do this. I went to a state hearing to find out what the state would ask my company if I were to develop something in agriculture with a residue contacting man. They did not have the facts at the meeting. It was a difficult situation. They had no chronic safety data, no mutagenicity data, on and on. We acquired reports on BST and articles written by the FDA and Science.

As our reviews were completed, various senators and representatives were contacted by us and asked to place questions on the FDA. Today we will concentrate on the questions and answers we received via representatives Scott Klug, retired, Second District of Wisconsin. We will provide you with references, and I understand there will be a panel discussion. I always call those barbecue sessions. There is nothing like a good barbecue.

We have asked the FDA such questions as follows:

How do you define a chronic health risk with a test of 90 days?

Did the FDA/Monsanto/Cyanomid and so forth collect any chronic health data?

If you thought enough of testing insulin-like growth factor, the co-hormone produced, in a bioassay, why did you cut off the test at 14 days? There are only 115 papers on this in the field of cancer, and we know that cancer tests require 18 months to two years, sometimes three. Why did they cut off the tests at 14 days? We will tell you why in a moment.

We asked why the growth effects on liver, as reported in the Groenewegen report, Journal of Nutrition 120:514, 1990, were not discussed in any article on BST. Where is the discussion of the consequence of these effects on the liver? Why is that? I will tell you where it is: It has been hidden intentionally.

I will give out this paper today. Mr. Armitage sent me a paper that was written by the College of Physicians and Surgeons. That paper omitted completely the only oral feeding study on milk that was ever conducted in the world. It was a 14-day study conducted at Guelph University by a Master's student. Talk about a thread of data to hang your entire society on. I have a definition of "fraud" that I will read to you at the end of this today, and you can see if it fits.

You should note in passing that this report was not referenced in the recent WHO report. The WHO report came out, and I sent them an extensive review that was hurriedly prepared when I heard they were to have a meeting. I thought it was a straight group. I sent them a long dissertation on diabetes, with lots of references, and to watch out for that one. They did not even cite that. I am just getting rolling here.

We suggested to Mr. Klug, after the FDA refused to respond to the technical questions for 20 months -- the average response time to a inquiry by our senators or representatives is two or three weeks. We suggested to that Mr. Klug that there was no health data on BGH milk and that the extent of testing was reported in Science magazine.

We also had an admission in New York Hearing 194 by Dr. Collier of Monsanto that 90 days was the extent of health testing of the pure hormone. Representative Klug decided to go to the FDA himself, as they had not properly replied. He confirmed our concerns that there was a complete lack of chronic health data.

Not being a scientist, Representative Klug asked the FDA to be interviewed by me on July 2, 1998. This is a first in the United States. I will read you the conclusions of that interview.

Dr. R. Livingston, FDA pathologist handling BST data, affirmed that BST was a zenobiotic material having a different structure from the natural hormone. An amount of impurity was mentioned but not defined. The amount of impurity we have seen is 5 per cent, as reported in Annals Research Veterinaria, 21 107s.

Metabolites and their fate in the cow were omitted. This means that in cow milk we have no idea of what fragments of rBST or zinc rBST may occur. Whether in cow or man, such fragments find any tissue, either randomly or by affinity, and lodge there. The FDA was unable to discuss at this sitting the binding of zinc peptide complexes to DNA.

Zinc mute proteins are the materials in nature which regulate human genes. They are complexes of zinc and protein. In this regard, I refer you to any modern text on biochemistry. These are the regulatory compounds which control many genes in our bodies.

Dr. Livingston indicated studies on the health effects of milk on any animal model were not done. There was not a single milk health test. This assumes they know all metabolisms. We can all fold our hats now. We can predict how successful our biology companies will be. We know everything; right? That is false, obviously.

We objected strongly to the complete omission of milk health studies due to the possible changed antigenicity of the milk and the increased amount of IGF-1 in some of the trials such as reports of Prosser and the New Zealand pathologists. We reviewed for Dr. Livingston some of my experiences with Vacor and the acute diabetes inductions. We then went through several compounds of concern as regards diabetes and milk, such as lacto-albumin and the 17 amino acid fragments thereof, which has been founded in diabetic human children as an associated material.

By the way, there is a scientist in Canada by the name of Hans-Michael Dosche at Toronto Hospital for Sick Children. He is one of the best biochemists in the United States and Canada put together. He deserves a lot of attention from your government. Give him a grant. Do something to help that fellow. He is a very good man. He is a quiet, unassuming person.

The research in Finland and France also showed that milk proteins were associated with diabetes in children. Their association was defined by antibodies in the children.

(0930 follows--Mr. von Meyer continuing -- when you have hundreds of children who have been analyzed and you find an antibody there that appears to be associated with diabetes)

GM/April 27, 1999

(Take 0930 Begins -- Mr. von Meyer continuing)

When you have hundreds of children who have been analyzed and you find an antibody that appears to be associated with diabetes, that overrules all of this armchair pathology upon which people write these reports, it is a higher order of data than a laboratory.

We wondered why bacterial toxins were not discussed in the science report since mastitis bacteria produced antigenic material such as endotoxin. The FDA did not have one single person who could discuss that with our laboratory. Yet they had hundreds of reports from farmers, and the farmers' union, of mastitis increases.

IGF-1 is a metabolite which increases in many milk tests where BGH and BST is used. It has been named myotrophin. The human drug myotrophin is a drug candidate for growing nerve cells in humans. It was petitioned to the FDA, by a company called Cephalon. The FDA commissioned a panel to review the petition. The panel rejected myotrophin as a human drug.

I will now show you that myotrophin was noted by the panel to cause increased human deaths after a long series of injections in a trial, which had a placebo versus myotrophin. While the FDA was telling the public that this IGF-1 is inconsequential as far as milk is concerned, and so on, it does not biologically act, inactive, et cetera, it was causing, in another division of FDA, increased deaths as reported by this panel. We tried to get the data by freedom of information and were denied. The only reason we got the report on myotrophin was because it was reported in Barron's magazine. Since you might not trust what I say, I have provided copies.

Next are the effects on the liver. We pointed out to Dr. Livingston that in several reports there were effects of rBST on liver weight. The FDA pathologist said he lacked sufficient recall to discuss this. Remember, the only milk health test in the world was done at Guelph and they did not recall it.

Apoptosis is the natural process of cell death which stops tumour cell progression. IGF-1 has now been found in the last three or four years to prevent apoptosis. Whether or not it could prevent it in the gut lining tissue is what everyone would wish to find out, would they not?

It is interesting to note that in any pathology discussions that I have had with dozens of pathologists that are board licensed -- I am not a board licensed pathologist, I am just a scientist of average merit -- they say that if you are to investigate colon cancer you do not want to do it in a rat. Why is that? They do not get colon cancer. They do not develop colon cancer unless you contact the average rat with a pretty healthy dose of carcinogen. If you wish to see if something enhances cancer, you get a rat, you get your compound in the presence of a strong carcinogen, and then test it in a rat. Generally a rat is a poorer animal for colon cancer. That has been published by famous people. One fellow did a study of mice and he predicted on the data that he would need to have 142,000 mice examined to find one colon tumour.

IGF-1 in humans is regarded as a potential human development for colon tumours. The reason for that is that it triggers a gene called the RAS oncogene. If there is a mutation in the RAS gene and you hit that cell with IGF-1, you may get more cell division resulting in a tumour. That is my simplification.

I will read you a summary of the points of the letter summarizing the meeting with the FDA. The summary replies to Congressman Klug and put in the congressional file.

a. Did you evaluate whole milk from rBGH treated cows in any health study of any mind?

Reply. No.

b. Did you consider and carefully evaluate the effects of recombinant hormone dried milk might have on diabetes?

Reply. No.

c. Did you consider the long-term impact of zinc derived peptides in the milk or trace the metabolism of rBGH?

Reply. No.

d. Were you aware that IGF-1 was fatal in a trial of its use as a drug myotrophin?

Reply. That would be in a different section handling drugs.

It is like these fellows live in caves or something. If I know that, and I am on a farm 500 miles out in the middle of nowhere, you would expect the government would know this that was reviewing the chemistry, would you not? You will know it here today.

It goes on:

e. Is rBGH and its residues a xenobiotic or foreign material to the human body?

Reply. Yes.

f. Discussion of mastitis bacterially produced chemicals was held?

Conclusion: no evaluation of toxins in herds from bacteria was done as it would effect either diabetes or Alzheimer's disease.

g. Liver effects.

FDA as evidenced by this discussion was unaware of the effect of rBGH on liver weight suppression by oral dose as reported by Groenewegen et al.

h. Did you analyse for minor peptides in foreign materials in rBGH milk by gel elctorphoresis or HPLC.

That is the only method that will pick up strange peptides formed by stress in the cow is gel elctorphoresis?

Reply. No. The only materials we analysed other than rBGH was IGF-I.

No test was done.

The discussion covered approximately 1 hr. and 15 minutes. Mr. Gold was present and in Washington a man from FDA information office.

I will not go through the rest of my letter here. I am a citizen of the United States and I strongly objected to what was going on there and I made some citizen like comments. I am sure you all get those from time to time.

Next are the specific concerns. Lack of diabetes data. In 1994, the American Academy of Pediatrics, volume 94, number 5 stated:

The avoidance of cow’s milk in the first months of life may reduce the development and onset of diabetes.

Why would that be? Well, something is going from the milk into the child at an early age which may trigger an antibody. That is the current pathology. The leader in the world in that is at the Toronto Hospital for Sick Children, Han Michael Dosch. He is one of the leaders in the world, together with a doctor in Finland. He has identified a piece of a cow protein called lacto-albumin.

The conclusion was reached by the paediatrics group based upon large scale studies of the epidemiology of diabetes in Europe. Such actual human data "trump" any short-term lab test or bedside opinion. The data involved long exposure of humans to the milk with blood analyses for antibodies in the milk. Discussions of the matter of diabetes and the environment can be found in our attachments here. I brought a book, which I will leave with you, on this subject. It is much better done than I can do.

(Take 0940 Follows -- Mr. Von Meyer: I wanted to thank honourable senators...)

 

(Mr. Von Meyer continuing)

I wanted to thank honourable senators for supporting the work of Banting and Best at some time in your past. They were the Canadians who discovered the structure of insulin, the insulin molecule. They were awarded the Nobel Prize in 1927.

World authorities on diabetes have shown an association between antigens and type I diabetes and cow serum protein. You would think that a government like yours and mine would say, "Folks, this is a red flag. Let us be careful about putting a new protein in milk that might affect childhood diabetes." Why? This is costly. Diabetes in the United States is not a rare disease. In terms of expenditure relating to treatment, 20 per cent of all medical costs in the United States is derived from diabetes. The United States has approximately 14 million people affected by diabetes.

In this regard, South Dakota State University tested rBST, as reported in the Journal of Dairy Science, in 1989. One of the key results was a strong increase in serum protein. The red flag is going up. Cow serum protein in the milk is shown in the following graph. One line is the control and the other one is the serum protein level in the milk. No one analyzed the serum protein to find out what it was. Was it something coming from the injured liver that was reported in the Groenewegen report. Was that injury from the liver leaking serum into the milk? Would that be a possibility? That is why we must be extremely careful. We must be careful again because they did not test the milk. Some of these things were tested for only 14 days.

It would be useful to determine after a year or more of the use of BST the small peptide profile in the milk by a careful chemical analysis. If we are losing hoof and bone material, and so on, and if serum is leaking into the milk, we better find out what micromolecular changes are occurring in the milk which could affect humans drinking it.

It should be recalled that FDA's Dr. Livingston stated that no metabolism and no small peptide residue studies were done. Often, the smallest molecular change can induce a disease. Thus, today, millions of dollars are being expended to find the root causes of Alzheimer's and muscular dystrophy. It takes us 20 or 30 years to separate out proteins that may be occurring at the picogram level or trillions and thousands of a trillionth of a gram. Those are often the causes of disease from long-term exposure.

My next graph addresses antibodies in diabetic children. This line represents the controls. This line represents the diabetic children with antibodies to cow milk protein. Is that not obvious?

That is not discussed in your report that Mr. Armitage sent to me. There is no graph like that in there. There is no liver data from the Groenewegen report. I believe there no liver data in there because industry is influencing these agencies over and above reasonable caution.

Antigens to a number of proteins have been found associated with autoimmune diabetes in humans. Autoimmune diabetes is diabetes caused by an antigen to yourself. There is some protein in your body, you may get arthritis, diabetes or an allergy.

The biochemistry of these substances in milk may lead us to prevent a disaster from chronic exposure to BST milk that may contain more antigenic substance. We have shown in these graphs data which was reporting cow serum. We have shown antibodies to these proteins being associated with diabetes.

The two enzymes that have been found to be associated with human diabetes are glutamic acid decarboxylase, GAD, and carboxypeptidase H, CH. These are products that are of concern because they may form antibodies in humans. Excessive mastitis bacteria may also supply them.

If I were testing, I would wish to leave you with things that you could use, rather than opinions. If I were to test this milk, I would look at the following six or seven items in the milk, just to be certain. First, I would test for lipopolysaccharide endotoxin; for glutamic acid decarboxylase, GAD; for CH, carboxypeptidase H; for islet cell antibodies, for cysteine protease and for gamma interferon.

The following should be noted. These are new data from 1997. The American Journal of Clinical Nutrition, volume 35, reported that 100 per cent of women who consumed two litres of cow milk per week showed beta-lactoglobulin. That is the cow milk protein in their breast milk. How many honourable senators have argued with me about proteins being taken up from the human gut?

One of your health officials got involved in a botulism case when a child died of botulism. Botulism is a protein that is taken up by the gut, transferred throughout the body in a matter of minutes and death ensues in about two days.

Choleratoxin is another protein toxin. If you mention these toxins to a biotechnology company, they will slam the door on you. They do not want to hear a word about toxins and proteins. That is why it is important for me to mention these things here. Biotechnology does not have to be a risk if it is properly tested.

From the aforementioned result being taken up by humans, we must assume that an active diabetogenic material would be not limited to children; adults might take it up. Unless you have the data, you will not be able to know that.

The next important point about diabetes risk is the incubation period. World authorities on this issue report that the incubation period is eight to eleven years on average, with some occurrence becoming apparent after six years of incubation.

The reason these incubation periods are long is that there is a repeated insult of the tissues by the milk protein or the antigen and the immune system takes a long time to develop a response and a significant time longer than two weeks. Eight to eleven years is 50 to 100 times longer than these things were tested.

The recent WHO report has only a casual mention of childhood diabetes. We discussed these antigens with them in detail and they omitted it.

Insulin-like Growth Factor-1, IGF-1 is my next subject. This material has been tested on humans and found toxic, but obtainment of the details has been difficult. The only public report is contained in Barron's magazine, attachment four. IGF-I was suggested as a diagnostic for prostate cancer.

(Take 0950 commences, Mr. Von Meyer continuing: Let us be realistic here...)

(Carrying Mr. von Meyer)

Let us be realistic here. In the natural environment, IGF-1 is bound up to another protein to the extent of between 90 and 95 per cent. When you extract tissues, in many cases you are separating bound from unbound, and for that reason the data may be faulty.

Research on insulin is difficult sometimes because insulin binds to glassware and plastic. When insulin is infused into humans in a hospital, the dosage used is generally higher in the infusion than that required to treat the patient. That is because early investigators found that 20 to 40 per cent of the insulin could bind to the glassware and the tubing within half an hour. I have shown you the structures of insulin and insulin-like growth factor. I will not review them but they are similar enough to have similar physical properties.

I will now go to Monsanto's freedom of information summary. We have below copied table 24 of the FOI document published by Monsanto, which summarizes the protein content of BST milk over a 252-day period. The results show a statistically significant increase of protein of about 0.1 per cent in the milk.

That may not sound like a lot, but in 100 pounds of milk that is 45 grams. If you drink 45 grams of something, it will affect you. Based on the previous report of the serum increase in milk, we suspect that these are serum components of some kind.

It should be noted that no gel electrophoretic analysis of this protein was done. Herein lay the risk of having an epidemiological change in a disease like food-induced diabetes over years of exposure to unknown materials.

Further, tests which would define the risk might not be doable on a small number of rats. This requires substantial discussion of how to estimate this risk because, with a population of 30 rats, you cannot detect even a 5 per cent occurrence of a disease consistently. They only used 30 rats for this test.

I will now you give you the data on the protein. Table 92 shows that after injections of 600 milligrams of BST red blood cell counts dropped statistically within three weeks and were down in all animal groups treated for three weeks or more. It is not known whether the drop in red blood cell count and hematocrit was due to BST directly affecting the bone marrow or some other message being sent from the metabolic change in the cow to the bone marrow. It is important that it is not known whether that message would transmit to any extent to the milk.

What is mess it would be if over 10 years it started depressing red blood cell development in humans.

In closing, we would like to address two questions we asked of the FDA and their replies. First; are short-term toxicity studies adequate to assess and identify chronic hazard from higher amounts of IGF-1 as would occur on farms where raw milk is drunk by children? About 99 per cent of farms drink their own milk. Are short-term tests adequate to predict chronic toxicity from all forms of BST?

Here is what the FDA replied:

The short term oral feeding studies are adequate for predicting the chronic toxicity of rBST and IGF-1 because the short term studies demonstrate that these proteins were not orally active.

I believe that we are up against get-the-money-and-run toxicology. Recently, we received a publication from the New York Academy of Science on a proposed conference on modern toxicology. The discussion will be chaired by Joshua Lederberg. My guess is that this is the opening round of many attempts to remove the need in some fashion to perform chronic feeding studies. I am opposed to this.

I understand that in the past few days an announcement was made by Monsanto that their pain killer Celebrix caused human deaths. We should have them discuss that, too. What did they do wrong in their testing that caused the deaths of 10 people?

Here I add the case for elimination of cows' milk. The FDA denied that any of the references in this 1993 paper had been published before BGH was released to the public.

I have provided corrections to the numerical data and reports of Monsanto and the U.S. Institute of Health. In the article in Annals Research Veterinaria the table numbers were changed. They were misprinted. They have two sets of data coming from the same set of animals. The article is void as of this day in the public domain, and this is the public domain.

In the National Institute of Health Report, the paper by Dr. Elsasser changed the decimal points of the residue of IGF-1 or rBST in the milk. They changed the residue from 43.4 to 4.3 after heat. That paper is void. The changes are acknowledged in the attachments that I will leave with you.

I have a letter from FDA to Science magazine acknowledging that the Annals Research Veterinaria article was incorrect. That is their major research article on BST before the science paper issued.

 

Senator Spivak: What is the date of the letter from the FDA?

 

Dr. von Meyer: It is dated April 7, 1994. I will read it to you.

This letter responds to your letter of March 14, 1994, regarding a comment …from a Dr. von Meyer…

In answer to his questions about the validity of information in the SCIENCE article, the information in the article is correct. It is the other referenced article (Ann. Rech Vet. …) … that is incorrect.

It is unchanged in the public domain.

The NIH did not change the residue numbers after heating the milk in the NIH December 5, 1990 report.

Anyone who has that in their file thinks that heat destroy all of these things. That is wrong.

(Take 1000 follows -- I enclose here a portion of a letter...)

RC/Agriculture 34842/April 26/99

(Mr. von Meyer: continuing.)

I enclose here a portion of a 1992 letter to Senator Robert Kasten, showing that when data in table 2 of the Science article were converted to a percentage of control, the weights of the liver, heart and kidney were all lower than the control animals by about 8 per cent to 10 per cent. They claim no effect on the liver. It is no wonder they do not want to cite the Groenewegen report which shows on two separate occasions there being an effect on liver.

Item three is a table showing the purity of rBST was not clearly defined during the developmental test period. In eight key reports, the purity of the material was only mentioned once. The high pressure liquid chromatography, or HPLC, analysis was never shown. The only oral feeding study involving BST milk was that done in Canada, a test which was conducted over the course of 14 days.

 

The Deputy Chairman: Dr. von Meyer several times now, you have mentioned 14 days. Was this the test done in Guelph?

 

Dr. von Meyer: Yes.

 

The Deputy Chairman: Can you explain what they did to the milk at that time? Were they not making a comparison to pasteurization?

 

Dr. von Meyer: Yes. As I recall, there were three cows from which they harvested milk which was then pasteurized for 30 minutes. However, the pasteurization process takes just a few seconds, not 30 minutes. They then had situations in which control cows were treated with BST. The milk from these cows was tested before being heated and after being heated. In every case in which heated BST milk was used, the resulting liver weights of the rats which were fed the milk were statistically significantly depressed. This shows that there is some oral activity.

In the Science article, the thymus gland of the rats which were treated orally showed an increase in weight, which suggests an immunological response.

Is that an adequate reply?

 

The Deputy Chairman: Yes.

 

Dr. von Meyer: Normally, if you have a statistically significant result in a short 14-day test on something that will be used by humans, would you not go back to your boss and say, "We better test this a lot more"? All those discussions were suppressed. I cannot image a young technician finding something that was significant on liver weights and not reporting back to his boss saying, "Boss, we have to go ahead with something longer here. We are getting some effects here." Instead of that, they cut it right off. As a scientist, that bothers me a lot.

 

The Deputy Chairman: Perhaps his boss was getting a grant from Monsanto.

 

Dr. von Meyer: I know they have a lot of grants out. You would know more about that than I would.

I discuss the phospholipid metabolism in my handout. This entire field of chemistry was omitted. It is too complicated to talk about that here today. I have already mentioned that insulin binds to glassware.

I wish to cite one other article from Science, which states, in part, that for 70 years medical schools have taught that proinsulin C-peptide, which is a part of the insulin molecule before it is released into the bloodstream, was found to be biologically active. We do not want to find out 50 years from now that BST milk was a primary cause of colon cancer or something like that, which is what I am getting at here.

Whether or not intestinal cells divide is not necessarily influenced by IGF-1. There are other chemicals that may do that. I have listed a report here. I have also included a complete copy of the Groenewegen report for your reference.

The one message that I want to leave here is that omitting this discussion in detail in the world health report and in the research report of the college of physicians is close to fraud.

 

The Deputy Chairman: Could you explain again what the Groenewegen report is?

 

Dr. von Meyer: This report shows that feeding heat-treated milk to rats resulted in reduced liver weights. I have highlighted here the critical evidence at which your committee needs to look.

 

The Deputy Chairman: Was that done in Germany?

 

Dr. von Meyer: No, it was done in Guelph, Canada, by your own laboratory. Why is that paper not discussed by the media, and so on, who are reviewing these subjects from time to time? What has happened to us? Where have we gone astray? I cannot answer all these questions.

I now wish to read to you will the definition of "fraud" as set out in Black's Law Dictionary. It states:

Fraud is either actual or constructive…it is something said, done, or omitted by a person with the design of perpetrating what he knows to be a cheat or deception…contrary to legal or equitable duty, trust or confidence justly reposed…it is an act, statement or omission which operates as a virtual fraud on an individual, or which, if generally permitted, would be prejudicial to the public…

In 1965, before genetic engineering came about, there was a shortage of insulin. They were trying to grind up cows to get the BGH out to see if it could replace insulin. It did not work, of course. It was shown that BGH was very specie specific. In doing this work, they ground up the chemical and digested the BGH with enzymes to see if any parts of it were active like insulin. Generally, it failed to replace insulin. What they found was that several triptych digests of BGH aggravated diabetes.

Thank you for you attention.

 

The Deputy Chairman: Thank you, Dr. von Meyer.

You have given us a different viewpoint on many different topics. Some of it we have heard before. We have also seen some of your documentation before.

I should explain why I am chairing the committee today. The chairman of the committee is home in Saskatchewan. He is an ever living optimist. He is planting grain.

(take 1010 follows: The Deputy Chairman continuing: You have expressed concern...)

(The Deputy Chairman: continuing.)

You have expressed concern that the evaluation of safety of rBST milk done by the United States Department of Agriculture's Food and Drug Administration has been done by nearly completely omitting any data.

Do you know if any further studies have been undertaken by this body to determine the healthfulness of rBST?

 

Mr. von Meyer: Not that I know of.

 

The Deputy Chairman: I gather you feel strongly that there should be further studies.

 

Mr. von Meyer: Yes.

 

The Deputy Chairman: Especially on milk going to children?

 

Mr. von Meyer: Yes. In the report by your Royal College of Physicians and Surgeons was the first time I saw any data on antibodies formed in rats from BST which was given to them orally. That bothers me a lot. Humans may form antibodies and respond to them based on the efficiency of their antibody system, and particularly based on a chemical called gamma interferon in the gut lining. That is a trigger compound for activating the immune system. Whether or not you will form antibodies depends a lot on that. They used hypophysectomized rats in those studies, which means they took out their hypophysis. I brought a paper here which states that it is commonly held that properly hypophysectomized rats will survive six to eight months after surgery. Nevertheless, such animals are deficient in many ways. One of these deficiencies is immunodeficiency. Immunodeficiency is the ability to form antibodies. Here we are measuring antibodies in a rat that has had its hypophysis removed. We measured it at 14 weeks, according to that report by your physicians and surgeons, and, according to the lifespan of the averaging hypophysectomized rat, that is a half-dead rat, a rat on its way out.

 

The Deputy Chairman: The expert advisory panel on human health did not recommend any long-term studies. Your view on long-term studies is quite well-known. You stated that they have been working on insulin for 70 years?

 

Mr. von Meyer: Yes, 70 years. They found a new discovery 24 months ago. The new discovery is C-peptide. It is part of the insulin molecule before it is released into your blood stream.

 

The Deputy Chairman: They always thought it was dormant or non-active?

 

Mr. von Meyer: Yes, but now they say it is active.

 

The Deputy Chairman: Do they know what that does?

 

Mr. von Meyer: Yes. That is being researched now. I have a paper in my handout on that.

 

Senator Spivak: I get the impression that the FDA did not do anything that was supposed to have been done in order to approve this drug. We had some indication of that from previous witnesses.

First, I should like to know if you think that this is atypical. Second, I should like to know why you think this happened. We have heard some comments about a revolving door between certain companies and the FDA.

I should also like to know what is the state of the appeal. I understand that there have been some senators and Congressmen and non-governmental groups who have appealed to the FDA to begin a review of rBST.

 

Mr. von Meyer: On the issue of the atypical approval scheme, you had three questions: Why was this an atypical approval; why did it happen; and what is the status of the review.

This is atypical. Materials that leave residues are generally carefully investigated for a minimum of 18 months of feeding studies or observations. All human drugs are investigated as to their metabolism. Even the modern animal drugs such as Ivermectim continue or drugs from Pfeizer for worm control or disease control in animals are all chronically tested.

This is very atypical.

Are there other cases? Yes. I am suspicious that the BT gene that went into crops was not tested as to its long-term effects on wildlife. I could only find data there about 90 days long. Some of the tests were only a couple of weeks in length. That bothers me.

In corn, the gene is not expressed in the seed, to any extent, but, rather, in the foliage which might be consumed as silage by cows or wildlife. I could not find any extensive tests on what that gene product would do. I am not an expert at this because I have not looked at that as much as I have looked at rBST.

This approval scheme is affected by the biotechnology lobby changing and getting into this monetary, hurry-up-and-do-it toxicology so that we can get the products into market or our company will go out of business. This is a result of the fact that these little biotechnology companies do not have enough capital to sustain themselves in the market to wait for the testing. The pressure that these people have put on to get them approved is enormous.

 

Senator Spivak: Why did this happen? Why is the FDA putting the speed at which drugs are approved ahead of the public interest?

 

Mr. von Meyer: The deputy director of the FDA is a man named Dr. Stephen Sundlof. I had my attorney go to one of the first BGH hearings to give a paper on what was going on in my mind. Dr. Sundlof was at the meeting, but not as an FDA man. He was from the University of Florida. He was supposed to be there as an independent advisor reviewing this stuff as if he was an unbiased reviewer. He did not say a lot at the meeting but he did make a number of pro-Monsanto comments. That statement of fraud that I mentioned included as a definition of fraud the omission of data critical to the public understanding.

A few weeks after the meeting, I picked up some science journal or magazine and found out that Dr. Sundlof, the professor from Florida, is now deputy director of the FDA. I looked back in my file and found that Sundlof was the former office mate of Dr. Robert Collier of Monsanto.

Here are the circumstances that are starting to pour down on my company and others who are interested. Dr. Sechen, the pathologist writing things up on this, is from Cornell University, who worked under a Monsanto grant through her professor. Dr. Sundlof is the former office mate of the director of research of Monsanto. Mr. Taylor, at the time the policy director of the FDA, is Monsanto's former attorney.

(take 1020 follows, Mr. von Meyer continuing: Ms Margaret Miller, who wrote the original WHO report…)

34842/Agriculture/April 26, 1999/DM

(Mr. von Meyer continuing --is Monsanto's former attorney.)

Ms Margaret Miller, who wrote the original WHO report, is the pathologist that omitted the chronic health data in the first place.

What is von Meyer and all the others who are interested in this up against? You cannot get a legitimate answer out of something like that. Does that answer your question?

 

Senator Spivak: It does. Thank you.

 

Senator Robichaud: Would we outlaw the FDA or Monsanto?

 

Mr. von Meyer: These things will happen. I have many things to say about this kind of thing, but not all of it can be made in public.

I should like to see several things happen here over a period of time. If I were Canada and heard about this, I would somehow want to become independent of it. You have some of the greatest scientists around here in Canada. There is no question about that. I would somehow get your system separate from these things that you know might be biased.

In my own country, I think that a committee of citizens must be appointed or elected to review things before they go into the FDA and to act as a wall here. We need to ask things such as, do we need this stuff? Would we rather have a leukemia drug for children or BST milk? We need some kind of committee that separates out the minor issues here. Someone made this discovery and they took it through to make money without a full realization of what the impact might be.

 

Senator Robichaud: You mentioned there were studies, one of two weeks and another for 90 days. You then mentioned that, after 70 years of study, we found something in insulin that we thought was very inactive. Surely, if we were to use the ultimate test of 50 years or 70 years, we would never get anything approved.

 

Mr. von Meyer: Or you would be cancelling several things.

 

Senator Robichaud: You mentioned that we have good scientists, and I agree with you. We are here looking at this issue because of the scientists from Health Canada who had the courage to come forward and say, "We are not satisfied that there has been enough study on this hormone, and we do not have data on it." The point was made that we did not have sufficient data on it.

I am concerned in these hearings about the cost benefits of this. I was in the garage one day where I usually have my car repaired, and a guy walked up to me and said, "I have seen you on TV. You are looking at that thing that they give to cows for milk. I am worried. I have three children. If I feel that this might not be tested fully and not good for the children, they will not drink milk anymore." If the children stop drinking milk, it will certainly have an effect on their health and their development.

Somehow, we must reassure here without being too pessimistic about the whole thing. We must give them the right picture. I am worried about that. Right now, I do not think we have all the information so that we can say that to the public without any doubt. Right now I feel that it should not be out there because I do not know enough.

I hope I get a credit towards a degree for the lessons we receive when people like you come before us to give us all this data.

 

Mr. von Meyer: You can get more milk. If you have a 20-cow herd and you need 20 per cent milk, you can buy four more cows. That is how I would get it. I would go a long time before I would put this into the entire population of the country without any chronic health data at all. This is an absurdity. That is what I am trying to tell you today.

 

Senator Robichaud: That is what the Canadian producers were telling us. There are other ways to obtain more production.

 

Mr. von Meyer: Yes.

 

Senator Robichaud: Still, it is being used in the States. If our producers feel that they are disadvantaged in any way or they could produce more with less, then, obviously, that is an incentive for them to try to use it.

 

Mr. von Meyer: That is the problem. The problem in Minnesota, Wisconsin and New York is that the milk price has gone down and down. Now that farm families are desperate for money to pay their bills for fertilizer, home repair, and everything, they are saying, "I must try this. If it will give me 10 per cent more milk, I will try it."

In Wisconsin, however, we have a label law. If you do not use BST, that milk will go to a dairy that purchases non-BST milk. That milk is labelled "non-BST milk." You can buy it in the grocery.

 

Senator Robichaud: You cannot test, then, for that hormone.

 

Mr. von Meyer: No, that is false. One of my attachments shows the method of testing. That is not the whole problem. The problem is that health testing of the milk, the whole milk composition, is unknown. The healthful effects of that milk are unknown. If you have focused in on a residue of BST, you might miss something in the cow's serum that got into the milk to affect diabetes. That is the problem here. You cannot just focus in on BST residues because your chance of having a diabetogenic milk could be as much that way or more if it was approved without the data under those circumstances.

This is a touchy thing. Is there any one here from Monsanto here? There are questions you might ask them. I am just presenting my side of this as a concerned scientist. I am not saying that I am always right.

 

Senator Robichaud: I understand that, and I thank you for doing just that.

 

The Deputy Chairman: One thing we should make clear here is that we have no shortage of milk. There was a shortage of butterfat in the United States of America, and the butter price there is still one-third or 50 per cent higher than it is in Canada because of the shortage of butterfat.

When I was Minister of Agriculture, my problem was to control production. If you provided farmers with a decent income, they provided you more milk than you knew what to do with. When I was first Minister of Agriculture, we had all the warehouses full of skim milk powder, cheese, and butter. The best business to be in was the cold storage or warehouse business. We do not need a product that will make your cattle give more milk. We have one-third less dairy cattle than we did 15 years ago, and we have 50 per cent less dairy farmers. We have more production of higher quality milk than we did before. We do not need something that will change the life of a cow and perhaps the life of a human being.

 

Senator Chalifoux: It might as be hard for you to answer these questions, but I have two comments and possible questions.

(1030 follows -- With all the data that we received in this committee)

(Take 1030 Begins -- Senator Chalifoux continuing:

With all the data that we received here in this committee, and the reports that have been made regarding rBST, it amazes me that the American health department approved this to begin with. I am hearing now that some of the senators and congressmen are demanding this whole thing be re-evaluated. Do you know what is happening right now with that?

 

Mr. von Meyer: I know what I have done. I have sent a very detailed summary, similar to what I talked about today, to a very powerful Senator in the United States, with hundreds of pages of references. My recommendation, very bluntly, was to review it. If what I said was correct, there should be severe reprimands, and possibly dismissals. This is just not done, what is being done here.

Can you think of any other product that was put in a national food item? See, you are drinking the body fluid. The milk is the body fluid of the cow. Can you think of any other product that was ever consumed, such a modified body fluid like this, without chronic health data? I cannot think of one.

There is another activist type group. I do not follow those things very much, but I saw it in the paper, where there was a petition that went to the FDA. When you petition the FDA, this is like dentists selling candy bars to me. You are petitioning the people you ought to be reviewing. I used to petition my brother to get the football on Saturday; I never won a single time.

 

Senator Chalifoux: As an aboriginal woman, I am very much aware that in our community now the diabetes rates are of epidemic proportion. It is much higher than the general population. The same is true for auto-immune diseases, such as arthritis and lupus.

I find your comments interesting on exactly what is happening. One of the reasons for this, according to the doctors, is that we live in the northern part of our country and have never have been exposed to a great deal of the non-traditional foods.

Do you think that in a community, where non-traditional foods have not been prominent over the years, that this could possibly have an effect on it?

 

Mr. von Meyer: Oh, yes, no doubt about it. There were some aborigines, I believe they were island people from somewhere in the Pacific who moved to Australia and got milk introduced to their diet. They had enormous immune response diseases. That has been published.

 

Senator Chalifoux: In Edmonton, in the Royal Alexander Hospital, there is a special department for treating aboriginal people with diabetes. There is, I think, some research beginning to happen there.

 

Mr. von Meyer: To me, after reviewing this, if there was anything that could be done to foster more investigation of diabetes, particularly at the Toronto hospital, where Dr. Dosch is a world authority. He could be a world leader in this, if his work was properly recognized and studied. He has been criticized for finding these associations with milk. You do not criticize someone who is inventing things on the frontier, you need to of help them along. We are critical of anybody with anything that might change the status quo.

 

Senator Chalifoux: I have another comment. I am not a scientist. I am a mother, a grandmother and a great grandmother. The minute I heard this, I had visions of our young men developing certain characteristics, and our young women, especially nursing mothers, with artesian wells. Maybe I am wrong, however, that was the first thing that came to my mind when Senator Whelan first brought this to our attention.

What are your comments on that?

 

Mr. von Meyer: You mention wells. The selenium element was tracked across the United States in relation to cancer. You could draw a map of certain cancers by the high levels versus low levels of selenium in the soil. Cows would eat plants in the field and pick up selenium and people would eat the meat or drink the milk in those areas and they were protected. For certain cancers, just having selenium in the environment may have an effect on the epidemiology of cancer.

I have studied many industrial deaths. People avoid me in debate on this issue. You would not wish to debate me, would you?

 

Senator Chalifoux: Not really.

 

Mr. von Meyer: You would lose, because when you see people who have been killed, and when you exhume bodies and analyze their gut contents, you become ultra sensitive to what might happen in a case where they do not have proper toxicity data.

Well water, environmental pollutants, milk, major foods that contact wide numbers of people, potatoes, corn, milk, meat, butter, cheese, those things must be watched at a higher level of competence than rutabaga or some uncommon seeds such as rapeseed.

Rapeseed and some of the crucifer seeds are very high in goitrin, the thyroid cancer inducing substance. The content can be as high as 1600 parts per million. I did some work on that 25 years ago. It seems like everything that is done is filed and then they go on to the next grant. What we need in some of these areas is continuous attention and scrutiny of health in the environment, not a grant deal and then on to the next grant.

 

Senator Rossiter: My question is supplementary to the answer that you gave to Senator Robichaud.

Why has the State of Wisconsin brought in this legislation that milk from non-rBST-treated animals could be labelled?

 

Mr. von Meyer: We had a battle like this in the legislature. I have been to the legislature five times down there with data like this.

 

Senator Rossiter: That is a couple of years ago.

 

Mr. von Meyer: It was in 1994, maybe. Wisconsin a highly rural community and was receptive to labelling the milk, particularly when I showed them a large amount of data with no health testing at all beyond two weeks. The label went through quickly. It was a close vote, however, it was a party line vote, largely. There were a few Republicans who crossed over to the Democrat side, where the health lobbies are in Wisconsin. It is not always that way.

The governor was accepting money from Monsanto; $160,000 in lobby payments. The former secretary of agriculture, Allan Tracy, was paid $3,000 for his golf club, by Monsanto. He is no longer with us. He has found an independent job. We will not stand for that in Wisconsin. There was a great uproar.

The milk is labelled there, however, it is not a strong enough label.

 

Senator Rossiter: There are still some farmers who use rBST though.

 

Mr. von Meyer: Yes. That goes into milk that is either unlabeled, or cheese. Eighty-five per cent of our milk production in Wisconsin is for cheese. Fifteen per cent is for home consumption, export and ice cream.

(Take 1040 commences, Mr. von Meyer continuing: The circumstances of the U.S. state...)

(Mr. von Meyer continuing.)

The circumstances of the U.S. state health departments depend on the directors of the state health departments.

Remember that the NIH report changed the residue data, that the science report did not review the Groenewegen report, that your own health department does not have the liver data in their review because they all filed after that initial FDA report.

When a state health department gets a letter from Dr. von Meyer, they say, "Who is he? Some jerkwater out in the plains, there, I will not put him up against the FDA."

The facts are that they have neglected the proper testing. There is a risk.

 

Senator Rossiter: The information about the greater incidence of diabetes is really stunning to me. For one thing, my husband was a diabetic. It blows my mind that this has never been discussed.

 

Mr. von Meyer: The number one killer of diabetics is heart breakdown, and then cancer of various organs.

 

Senator Spivak: In our health protection branch, there is review or a restructuring which is ongoing. They understand that there will be an increase in the proposals for bio-technology products.

Given that all these huge companies are now dropping their chemicals and going into life sciences, they are not doing that for their health, they are doing it because they see an immense amount of profit in it.

Our laws here have quite a stringent mandate, as to what should be done for the testing of drugs. Given what you are saying, and I understand that chronic toxicity is not something that can be tested in 30 days. I do not see a real understanding that this is what we must do before we unleash these drugs on the public.

Again, we are not talking about drugs that have a therapeutic value, or things which have a therapeutic value, but often, as in the terminator gene, something which protects investment, or something that is good for commercial reasons.

I assume the situation is similar in the United States. In addition, you have this intensive lobbying and infiltration of people at international bodies, who, perhaps, do not attach the same weight or gravity to the need for testing of chronic toxicity.

What is your view of how we will deal with this challenge? What will we do with these bureaucratic institutions, and with the influence of companies, in order to put us in a position where we can assure the public, to have some confidence, and not to consistently be in a state of worrying about what they are drinking.

 

Mr. von Meyer: I contributed to a book 25 years ago, after I had been through deaths of people and cancer with by-products in the fungicide business, cancellation of two or three major herbicides and the stress of that mess.

I put forth a profile of biological tests that should be used and well understood before a major food residue is placed in the public domain.

About half of those tests were omitted in the case of the Monsanto growth hormone. If I had to rewrite that article that I wrote back in the 1970s, I would add diabetes, specifically, because we now know by absolute observation of our whole population that diabetes now occupies 20 per cent of all of our causes.

We know from Senator Chalifoux's genetic group study that it is important. We must give greater emphasis to certain diseases that may be enhanced by protein antibodies. If I were to rewrite that profile, I would add diabetes and Alzheimer-type models.

What makes things worse today is that men and women are living longer. They have a longer period to express these diseases. The last 10 or 15 years of your life should be as rich as the first 15 years.

A profile of tests should be developed that would protect the public and the kinds of data. If you have someone in the review system who is corrupted, no matter what you write down, it is shot. That is why some kind of a citizen panel is essential to starting these things.

Will your government accept every one of 1,000 different bio-tech products, or will they confine their efforts to those things that are very important and significant to start with?

 

The Chairman: You were asking if anybody from Monsanto was here. We invited them to come today and they refused to be here. They do not know whether they will appeal the decision that was made by the health department. They are concerned about the Canadian Veterinary Association's report.

We did invite them. We have invited a couple of other people who have told us they will not come. We may have to subpoena some of them. I do not know yet what we will do. It is up to the committee to decide.

We have had a significant amount of discussion with Codex Alimentarius. What do you think of that organization?

 

Mr. von Meyer: People who sit on their committees reported to me 20 years ago. They often only get data that are thoroughly fleshed out. The controversial stuff that occurs within a corporation sometimes never gets out of the company to the Codex meeting, or the EPA or some body such as that has fleshed it out and then it is summarized at the Codex meeting.

 

The Deputy Chairman: I have not studied the make up of this organization for a long time, but are they all scientists?

 

Mr. von Meyer: I have not looked at it lately, but, no, I do not think they are. Some of them are politically appointed. I know we are recording this, but this bothers me a great deal.

 

The Deputy Chairman: It has been suggested that maybe a couple of members of this committee should be members of the next meeting we have in Rome.

 

Mr. von Meyer: That is not a bad idea.

(Take 1050 commences, The Deputy Chairman: Someone said that they are not scientists...)

Victoria Aucoin /April 26, 1999/Agriculture #34823

(Following Take 1040, Mr. Von Meyer: That is not a bad idea. TAKE 1050 begins here)

 

The Deputy Chairman: Someone said that they are not scientists and they should not be there because this is a highly scientific meeting. We have heard that when they vote, some of them vote contrary to how their government or their Parliament wants them to vote.

 

Mr. Von Meyer: I do not think they should have any determinative active power on either a body like this or on government. They can publish documents and decisions. They did a poor job with me, though. All they were doing was omitting information. However, they will not succeed in this, because people like you will ask people like me to say something.

 

The Deputy Chairman: You do not have to answer this if you do not want to do so, but what do you think about our scientists in Health Canada who went public?

 

Mr. Von Meyer: The scientists who went public with criticism of this review are heroes. The discussion regarding the cancellation of BGH in the animal health field -- that is, the action that you took a few months ago -- was headlined in the Madison and Wisconsin papers with a one-inch high header. The people there have been fighting this thing in Wisconsin for seven or eight years. The newspaper editor did not cover all the technology, because they do not report everything they should sometimes, but you people are regarded as heroes in Wisconsin.

 

The Deputy Chairman: Health Canada has said that there will be no rBST, but we are getting a lot of products from the United States of America, such as milk which is made from cows that are injected with rBST. According to the information that we have been given, a huge amount of dairy cattle in the United States have been injected with rBST.

You spoke before about diethylstilbestrol. When I was Minister of Agriculture, we would not let an animal into Canada that had been given diethylstilbestrol because we did not want it. We had to get a veterinarian to sign that an animal had never consumed or been implanted with that drug.

 

Mr. Von Meyer: We have a law that recognizes BST-free products in Wisconsin. Your government could ask that products only come from those farms. We already know who they are. If you want to get BST-free milk from Wisconsin, it would be easy for our people to provide only BST-free products.

 

The Deputy Chairman: Under NAFTA, if they have been exporting any products into Canada, even if you find strong evidence that it is not a good product you cannot stop them from exporting it into our country. If you do, then you will have to pay them compensation. We just went through that with MMT.

 

Senator Spivak: You do not have to do that. You must go to a dispute settlement mechanism.

 

The Deputy Chairman: I agree with Senator Spivak that I probably would have gone to the highest court in the land to appeal that decision because the corporation that makes the product is not even allowed to sell it in the state in which it is made the United States.

We have many more questions for you, but we will hear first from the other witnesses. We will ask you to return to our panel discussion later.

I would ask our next group of witnesses to come to the table at this time.

(TAKE 1100 follows, The Chairman continues, Dr. Stuart McLeod, the floor is yours.)

(The Deputy Chair continues)

Dr. Stuart McLeod, the floor is yours. Please proceed.

 

Dr. Stuart McLeod, Human Safety Panel: Good morning. I was invited to join you this morning to answer questions about the science related to recombinant bovine growth hormone, the effects that it may have on cows' milk and the indirect effects it may have on humans.

As you know, I chaired a committee for the Royal College of Physicians that looked at these issues in considerable depth over the last six or seven months of last year and presented a report in January of this year.

I think our report was commendably brief and very direct, with very simply stated conclusions. Our committee did not believe that there was evidence of significant human risk associated with the use of rBST in dairy herds. We had a concern about one of the studies filed by the manufacturer with Health Canada, and we noted that in our report and suggested that the study should either be repeated or the results discussed in depth with the Bureau of Veterinary Drugs. However, in simple terms, we found no evidence with any biological plausibility to suggest that milk from cows treated with bovine somatotropin posed any particular risk to human health.

I would be happy to answer questions in relation to the specific items of concern to this committee, or to Health Canada scientists.

Dr. Michael Pollak is with me. Michael was a key member of the committee and is an internationally recognized authority on insulin growth factor, which I think is the central concern with regard to human safety as impacted by product.

 

The Deputy Chairman: In the report of this committee we recommended, among other things, that no notice of compliance be issued until the manufacturer submits the long-term studies on human safety identified by Health Canada's rBST internal review team.

Dr. Pollak, do you wish to make some remarks?

 

Dr. Michael Pollak, Human Safety Panel: Thank you. I am a professor of medicine and oncology at McGill University in Montreal. We have been studying insulin-like growth factors in the context of cancer for many years. I was asked to sit on that committee. I should like to offer this committee my perception of the overall process in which we found ourselves.

First, I agree with the prior witness this morning that the Health Canada scientists who did not rubber stamp the application from Monsanto could be described as heroes. There was enough cause for reasonable concern that they were correct in saying that this is not a rubber stamp issue, that it requires further thought.

I agree with your remarks that the context was certainly not one of urgency because we are not suffering from lack of milk.

(Take 1110 follows -- Right away we had a situation in which...)

RC/Agriculture 34842/April 26/99

(Mr. Pollak: continuing.)

Right away, we had a situation in which the risk-benefit picture was one where not only was it reasonable to ask for a closer look but there was no downside because we had no emergency. It is not as though we had a batch of crucial vaccines that might have had some kind of health hazard.

Although it did not work easily for the people involved, the process worked and they should be commended.

That having been clearly understood, we embarked on a more detailed look, which had to be done, on whether the health concerns were real.

I will say again that it was very important that we did that and that was the right course of action. When we did look, especially with respect to the insulin-like growth factor story, while we were glad we were asked to double-check, it turned out that the double-checking exercise was, in fact, reassuring, rather than otherwise.

With your permission, I will give you a few minutes of description of what we found. I brought with me today a recent issue of a well-known cancer scientific journal, The Journal of the National Cancer Institute. I happen to have a paper published in this journal which relates IGF-1 levels to the risk of colon cancer. The higher the level of IGF-1 in your blood, the more likely you are to get colon cancer. It is a concern. It is a new finding. It is new science.

There was an editorial in this issue of the journal commenting on that paper. The title of the editorial is, "Insulin-like Growth Factor: A key regulator of human cancer risk?" It was written by some eminent scientists in the U.S. who thought this was a big concern.

How can we put this together? There is a process that I would like to explain to you. Why did we feel that our second look was reassuring, even though I am contributing myself to the data which says that serum IGF-1 levels are related to cancer risk?

The issue is the following. There is no good evidence that we could find that dietary habits are a determinant of serum IGF-1 levels. Thus, it is true that the cows have more IGF-1 if they are treated with growth hormone. It is also true that children who are treated with growth hormone have higher IGF-1 levels. The missing link here, which makes it impossible for us to finger Monsanto or the product as dangerous, is that we could not find any good evidence that drinking milk of any kind, BST treated or non-treated, is determinant of the circulating IGF-1 level. Therefore, you see where we are coming from on this particular aspect of the risk.

It was close. The emerging scientific data looked worrisome. There was no emergency. The Health Protection Branch employees who said, "Wait, study closer," did the right thing.

We did study closer. We reviewed the data. The growth hormone treatment of the cows causes increased IGF-1. People who have higher IGF-1 levels in their blood have more cancer risk. The data to support that is getting stronger every day. However, the link which is missing is that consuming the BST milk does not raise your serum IGF-1 levels. Therefore, we were unable to prove any kind of cause-effect relationship.

In terms of risk benefit, we do not have in the real world anything that is completely without risk. In my view, and I am just speaking now as an individual, I am not a fan of the BST treatment of cattle for human milk production. That is not because I can prove that it is a risk from the point of view of cancer. I agree with the chairman when he says that we do not have a problem of milk deficit so it is a proposed solution to a problem that does not exist.

As an individual, and as a scientist, I can see lots of intelligent uses for biotechnology, to make crops that are resistant to drought. If they are safe and also resistant to drought, that is progress. However, here we see something where some people have concerns about safety. I am not so convinced that the safety issue is as crucial as some people believe. However, on the other side, I do not see any real pros for going ahead with it. Therefore, as an individual, I am not in favour of it, even though I cannot prove that it is dangerous.

In closing, we have to have some kind of a level playing field here. I believe that we should be very careful about our food supply. We should err on the side of caution. On the other hand, consider all the stuff that is unregulated. Look at the food stuff in the health food stores, including all the herbs, additives and supplements. We do not have any data about the long-term monitoring of these things. We have very alarming products being sold, such as alcohol. We allow products to be sold which we know are very dangerous.

I can see all sides of this. I can see that we could easily be accused of being hypocritical if we say that BST is not completely safe because we do not have 20-year follow-up data, so do not let it in. What about alcohol? It is a big health hazard and we let that in. Where is our consistency?

 

The Deputy Chairman: You are making a comparison between alcohol and milk which are complete opposites. We have taught mothers about breast feeding.

I was exposed to alcohol every day of my life and I did not become an alcoholic because I did not have to have it. I did not develop cirrhosis of the liver because I did not have to have it.

 

Mr. Shiv Chopra, B.V.Sc., M.Sc., Ph.D., Health Canada: Mr. Chairman, I was not at all prepared to be here today. It was sprung on me suddenly. As such, I have not brought any papers or reports with me.

I live with this issue every day, and have for the last 10 years. Therefore, I think I can respond to some of the issues.

The issue I want to deal with does not have so much to do with science. That is not because I am unable to deal with it or because I feel inadequate in any way, both in terms of giving my own opinions or giving a critique on what is before us at this very moment.

I have some very serious concerns about the appointment of the two external panels, about the history and the background and what followed. Dr. McLeod appeared before the report was written. Thus, some of the concerns were in the public domain. The panel was already in the works. One of the remarks that appears in his report is that they did not go into the process part of the evaluation at Health Canada.

That may be all right from his point of view. However, as an eminent professor at a university and as a researcher with this huge responsibility on the side of public safety, there are certain responsibilities that have to be taken into consideration when one takes on a position like that and puts his signature to it.

That is a parallel with what happened to me personally because I was the first instigator. You all call my colleagues and I heroes. We are not here to be heroes. We are also not prepared to be sacrificial lambs either in the hands of our managers. We are just doing our jobs. That is incumbent upon us. It is required under our oath to the public service. That is why we are here to testify again.

(take 1120 follows Mr. Chopra continuing: It was this concern....)

 

(Mr. Chopra: continuing.)

It was this concern, and my attitude to my job as a 30-year public servant, that caused me to approach my management, saying there are serious problems covering the last 10 years.

The word "fraud" has been used about FDA. FDA has commented on the rBGH report, the gaps analysis report. Secretary Shalala has criticized it. The FDA has criticized it. It has been said that Health Canada scientists misinterpreted the data or did not do an adequate job. They are the ones who are under the scrutiny of the whole world, and words such as "fraud" have been used with respect to them, as well as JECFA and Codex. We ourselves, although we have not used the word "fraud," have used the word conspiracy, which is pretty close to it, regarding our managers at Health Canada.

Those are our grievances. That is the background. Before we came to you, we had gone to court. We will be appearing back here on May 3, and then we will deal with those concerns in more depth.

I want to raise a question here before you, Mr. Chairman, and senators. If an external panel takes on a job, they know the background and there are certain things they have to ask. One question is: Is this panel aware of the Food and Drugs Act as it applies to veterinary drugs? If they are, then are they aware that animal safety at Health Canada is an integral part of human safety? It is not for the cows' safety that Health Canada does the work on animal safety. If it were, then this area should be sitting in Agriculture Canada or somewhere else. It would not be in Health Canada. When we look at the issue of rBST, we are looking at the health of the cow because, if there is any physical effect or any change that occurs, any medical person, any toxicologist, any pharmacologist, would call it a pathological effect. If the cow's haemoglobin changes, if there is a disease process, if there is an inflammatory response if any kind, if there is an IGF increase, these are all responses as a result of giving a product.

 

The Deputy Chairman: One moment please. We are supposed to be discussing this panel's report, and I think you are getting a little far afield here.

 

Mr. Chopra: I just wanted to set the parameters of what I want to say, because I was suddenly brought into it.

 

The Deputy Chairman: You will be back here next week, too.

 

Mr. Chopra: I will not deal with that any further, then. The issue still is IGF-1. No one knows if it is the cause of cancer or the effect of cancer. That has been said in our previous presentation, and I think that is what most people would say. IGF-1 is one of the growth factors that occurs whenever there is cellular growth in the body. Whether it is happening because of cancer or just induction in milk, there is an increase in IGF-1. It is an indication that something has changed. It goes only as far as that. I have not said that IGF-1 could be the cause of cancer, but it is an indication that something is wrong in the cow.

The human health panel has also not commented on the immunological study beyond the possible allergic effect in humans. The allergic effect occurs only in 2 per cent of the population. That is a normal incidence or prevalence of allergy in the human population. People can be allergic to anything. If you are talking about an increase of mastitis as a result of antibiotic resistance, the only thing we noticed in that report is residues, and residues possibly precipitating an allergic reaction in people. That is not what we were saying. We were saying that this product, given orally to rats, has produced antibodies to rBST when it should not have.

The FDA had said this product is biologically inactive. That was a fraudulent report. That report was not recognized. It was not mentioned in their FOI. It was not mentioned in the reviews. It was not mentioned in Health Canada reports. Only the gaps analysis report discovered it. It was sitting right under our noses in our department.

When we discovered it, all we had discovered was that something wrong had happened and that it was contrary to what the department and others were saying, which was that it is biologically inactive. The only thing it showed was that it did get through the rat mucous membrane, through the intestine, and had produced antibodies. As a result, it required further investigations. They were saying it will get digested away. It did not get digested away. It produced antibodies.

I want to deal with the issue of amounts. The point has been made that the amounts of IGF-1 are low. What we are talking about is the toxicology, not of the amount that will produce cancer in a whole body. We are talking about embryonic cells. We are talking about sterility in males, infertility in females, and possibly induction of cancer. These are embryonic cells. You are dealing with single cells.

The human female embryo, by age 54 days of pregnancy in the uterus of her mother, is a fully formed human being with all of the 300,000 eggs that she could potentially produce throughout the her life.

 

The Deputy Chairman: I think we are going very far afield. Dr. McLeod, you wanted to make an interjection?

 

Mr. McLeod: I really did. You have already raised my point. I forewent the opportunity to make an opening statement. I could have read to you my committee's report, and I declined to do so. Many of Dr. Chopra's comments are of some interest, but they are really not the substance of what I think we were invited here for today, which is to answer your scientific questions about our report. I really would prefer if you listen to Dr. Chopra at another time.

 

The Deputy Chairman: I think Dr. McLeod has a point. We will now go to Dr. Michael Hansen.

 

Dr. Michael Hansen, Human Safety Panel: Thank you very much. I am glad to be here again. I was only notified last week about this meeting, so I do not have anything written. I will get you some written comments as soon as I get back to the United States.

 

The Deputy Chairman: Dr. Hansen, can you tell us who you are?

 

Mr. Hansen: I work with the Consumer Policy Institute, which is a policy research wing of Consumers Union of the United States. They are the publisher of Consumer Reports magazine. We have been very active on the bovine growth hormone front. I was also invited as a technical expert to the Joint Expert Committee on Food Additives, the JECFA panel, that met in 1998. I disagreed with what they did there, but I went through some of those disagreements when I appeared here last.

I would like first to discuss some of the concerns or the disagreements that I have with this human health report that Health Canada put together. This may be a little tangential, but I noticed that, on their website, it is being called a report of the Royal College of Physicians and Surgeons of Canada on rBST.

(take 1130 follows, Mr. Hansen continuing: Yet, in this letter from the Royal College...)

 

34842/Agriculture/April 26, 1999/DM

(Mr. Hansen continuing -- a report of the Royal College of Physicians and Surgeons of Canada.)

*** Yet, in this letter from the Royal College dated November 18, it says that the expert panel is not a committee of the Royal College and that the panel which has expertise in these areas is an advisory panel to the Minister of Health.

I note that it is interesting that Health Canada calls it the Royal College of Physicians and Surgeons report when the Royal College itself says it is not a committee so it is not one of their reports and that they were just an advisory committee.

As well, in the executive summary, they state that there is a biologically plausible basis for which to conclude rBST associated changes in human exposure to IGF-1 will have any immune response, lead to any immune response, change in neonatal intestinal growth and development, or cancer risks in recipients of milk or food products from treated cattle. I have concerns with that statement, and I will go through them.

Before I do that, I will say that I agree with Dr. Pollak in that we do not have hard evidence that dietary habits have an effect on serum IGF-1 levels. We also do not have hard evidence that IGF-1 or some of these compounds are problematic. The problem for some of those who have been critical of this is to say that there needs to be the appropriate research done. The absence of evidence is not evidence of absence of any effect. The fact that they did not do the long-term studies is significant. If you say we do not see any strong evidence that shows there is a problem, I would agree with that, but there are questions that need to be answered.

The problem I have with some of these statements is that, if we first go through and look at the immune response, they say that its pharmacological properties are indistinguishable from its natural bovine counterpart. On page 13, they also say that the panel is concerned about the indication that rBST may cause an immune response in rats; however, such reactions would occur in response to natural as well as to rBST.

I would disagree with that for one main reason. This notion that it is pharmacologically indistinguishable and identical is not really true. The Monsanto product is slightly different from the natural pituitary form. There is a substitution at the amino terminal end of a methiamine for alimine. A paper published in 1994 in the Journal of Immuno Assay titled "Identification of Antigenic Differences of Recombinant and Pituitary Bovine Growth Hormone using Moniclodal Antibodies" found, using those moniclodal antibodies, that the met rBGH of the Monsanto product reacted twice as strongly, so there was a difference in the immunogenic and potentially allergenic response.

This notion that since we saw something in the rats it will be exactly the same for the natural sequence is not necessarily the case. Again, we know that antibodies reacted more strongly, these monoclodals, to the recombinant form compared to the natural. That means the statement that it is indistinguishable from its bovine counterpart is not particularly correct. I would take issue with that.

On the issue of neonatal intestinal growth not being a problem, they, in part, try to dismiss that by saying that with respect to local effects of IGF-1 on the intestinal mucosa, because human milk has a higher IGF concentration than milk from rBST treated or untreated cattle, if the slight increase in AGF-1 concentration of milk in rBST treated cattle would have an adverse biological effect, human milk would theoretically have a greater adverse effect.

While that might be true, I would point out that humans do not normally drink milk after the age of four years old. You cannot really compare infants and young children getting human milk when they would be getting the natural growth factors they need to people drinking milk for 30, 40, or 50 years and try to dismiss the effects of IGF-1 that come from long-term consumption of milk over a lifetime. What 30-year-old drinks human milk? Not too many. Hardly any. And they are not drinking it every day.

I would also point out that the European Union Scientific Committee on veterinary measures relating to public health aspects and the use of bovine somatotropin put out a very detailed report on the human health concerns that came to different conclusions, and they pointed out that there was a concern with the patho-physiology on the gut and that more research needed to be done. I will go into that a bit later. There is a disagreement there.

They also, in this report, stated that the JECFA analysis was complete and accurate, and I have a problem with that.

Part of their argument for why the IGF-1 is not a problem is that they say the amount is less than 1 per cent of the level that is in the gut. It says it is reasonable to conclude that is it is unlikely that the long-term consumption of the additional amounts of IGF-1 in milk constitutes a hazard to humans and it is difficult to envision local effects induced by IGF-1 on the gastrointestinal tract in view of the fact that one is introducing an amount equivalent to a maximum of 0.8 per cent of indigenous IGF-1 in the gastrointestinal tract. They go on to say that when you test hormones, that chronic testing should be looked at if there is more than a 1 per cent increase in exposure.

Much of this is based on the levels of IGF-1 in milk that they have in their Table No. 3 for the report. The references refer to the Science magazine article from 1990, and the problem is that the values that are in this table do not jive with the ranges that are indeed reported in the Science article, and, if you go back to the original JECFA paper in 1993, they do not jive with those either. They say the concentrations in bovine milk range from 1 to 9 nanograms per millilitre, and in milk treated with rBST, from 1 to 13, and the references they give are 14 and 39, with 14 being the Science article. If you go back and read the Science article, you will see that in certain studies, the level in milk in the control cows was 28.4 nanograms per millilitre. In the treated cows, it was 35.5. Those levels are much higher than the 1 to 13, and those are the levels that they use to argue that there is less than this 1 per cent increase in the gastrointestinal tract. The table here is incorrect when they have these ranges. In fact, I have pointed this out previously in papers that we did for JECFA and when we were criticizing this to the Food and Drug Administration.

In the European Union scientific committee report which came out in March, they pointed out that there is actually a problem with some of the tests that are used to measure IGF-1 levels in milk and that there is this variability here. They did not try to standardize that, so it is hard to compare. As well, they pointed out that there are actually several forms of IGF-1. There is a form of IGF-1 that has three of the amino acids at the terminal end truncated, and that dethtripeptide IGF-1 actually has a potency, as the scientific committee in the EU pointed out, up to 10 times greater than normal IGF-1. It has also been pointed out that when you use the normal radio immuno-assays that are used to detect the IGF-1 levels, they are far less efficient at detecting this truncated form.

The fact is that we do not know accurately the levels that are in milk throughout the lactation and throughout the time after the cow is being injected. Some of us have been trying to get data because we think that the IGF-1 levels in the milk will probably rise in the first few days after the cows are injected with IGF-1, but the only data that Monsanto has ever published, even though data was taken on a daily basis, is the midpoint of the cycle.

(1140 follows--This product is injected every 21 days)

(Take 1140 Begins -- Mr. Hansen continuing)

This product is injected every 14 days, and they only give you the IGF-1 values at day 7, at day 21, at the mid-point of the cycle when it could be going up and coming back down. We do not know. You need to know what the real IGF-1 levels are. We do not.

There are problems. As the scientific committee report in the EU pointed out, that is an incomplete area and one where there is need for further research. They say, and I quote:

The available databases for exposure assessment, i.e., the amount of IGF-1 and or its truncated forms excreted in milk following the administration of rBST to dairy cows is incomplete.

I feel that an important consideration. Also, this argument that the levels that are normally there in the gut are so much higher. You must look. The data has come out from scientific papers that show, in an in vitro model, that IGF-1 in a free form, its half life is less than two minutes. In the presence of casein, which is the major protein in milk, it is over half an hour, over 17 times as long. When you are looking at the levels in the gut, you cannot only look at the total quantities and say that there is a little bit here in the milk and there is so much more in the gut. The stuff in the gut is in the free form, which means it is being continually turned over and broken down rapidly, whereas the amount that is in the milk is staying around for a much longer period of time. That is theoretically like there is a higher concentration. The concern we have had is that it does provide digestion, because initially the FDA said it did not, and we now know from studies in rats that indeed, in the presence of casein, most of the IGF-1 does indeed survive digestion. Therefore, if it is getting into the gut, the concern is what does it do not gut lining cells. I am not as concerned with the plasma levels as I am with the levels that are actually in the gut and what that might do to colorectal cancer cell lines.

There is a paper that I brought with me, called the Growth Regulation and Co-stimulation of Human Colorectal Cancer Cell Lines, by insulin like growth factor 1-2, and transforming growth factor alpha, and they found that IGF-1, in an in vitro model, in 5 out of 8 human colorectal carcinoma cell lines, they had a 50 per cent increase in growth rate in those cell lines at 1.9 to 6.5 nanograms per millitre of IGF1. Those are the levels similar to what may be there in the milk. If it is getting through, there could be a stimulation there.

This is important and deserves further study. That is why I believe there needs to be further study and the notion that there does not need to be any chronic toxicity testing is not correct.

Actually, on that issue, I find it very interesting because I actually have a quote from Dr. David Kowalchuk, who is a research director at Monsanto. In 1986, right after he joined Monsanto, there was a symposium on new perspectives in veterinary pharmacology and therapeutics. In a paper which he gave, entitled Peptide Pharmaceuticals he said:

Even though we may be dealing with an indodgenous compound, a thorough evaluation of its acute and long-term toxilogical effects still needs to be performed since we are dealing with potent compounds that have more than one effect on physiological and biochemical functions. From a safety standpoint, an indodgenous compound, which is only used for a short time, will have a low probability of producing toxic effects. However, the long term use of production products such as bovine somatotropine for increasing milk production over several lactations has a greater potential for inducing subtle changes in the physiological or biochemical homeostatic mechanisms that may be irreversible."

That is Dr. Kowalchuk, a Monsanto scientist, talking to over scientists in 1986.

I would also point out that the panel also failed to look at a paper that was done by Burton McBride, published in the Canadian Animal Health Journal, where they also concluded that more research needed to be done. I will read to you from the summary. It says:

To date studies evaluating the activity of ingested rBGH or IGF-1 have only determined that these hormones do not induce gross anatomical growth in weaned rats. Although these are the two most obvious proteins whose concentrations in milk can be changed as a result of rBGH treatment, the possibility remains that the concentrations of other bio-active proteins in milk are also altered during rBGH treatment. Experiments to explore this possibility need to be conducted. Such experiments should include: One, the full characterization of hormones in bio-active substances in milk from rBGH treated cows, including compounds such as prostiglantins, oreatropoitin, progesterone, prolactin, thyroid hormones, gonaditopin releasing hormone, thyrotropin releasing hormone, growth hormone releasing factor, basoactive intestinal peptide, epidermal growth factor, estrogens, relaxant, plasmin, interlukins, tumour necrosis factor, insulin, IGF-1, IGF-2 and growth hormone; two, the feeding of milk from rBGH cows to neonatal primates to determine the effects on gastrointestinal tract development absorption and function; and three, the effect of consumption of milk from rBGH treated cows on immune recognition and subsequent immune functions in the gut.

There is another scientific paper that says there needs to be long-term toxicology studies.

The only other points I wish to make is that you should look at the scientific committee report from the European Union that looked at human health. They go through the range of these problems systematically and say that there needs to be further research done here, because we cannot conclude that it is completely safe.

Finally, to deal with the antibiotic residue issue, the panel just dismissed that very quickly. They said, and I quote:

It can be assumed that this increase in the incidence of clinical mastitis will result in a corresponding increase in the use of antibiotics. It is highly unlikely to have any impact on the important public health issue of increasing of antibiotic resistance. Although anti-microbial resistances is linked to exposure of bacteria to anti-microbials, the amount of increased exposure as a result of the treatment of this condition would be marginal in comparison to other agricultural and human uses. The quantity of antibiotic use for the treatment of infections in animals is insignificant as compared to their long-term use as growth promoters.

I agree with that, however, it should be pointed out that studies have shown that antibiotic residues that occur in milk in the parts per billion range do indeed increase the rate at which bacteria evolve resistance. If you look at staphylococcusorius, data that was done at Rutgers University, showed that when there was a residue of one antibiotic in the 10 to 100 parts per billion range, you had an increase in the rate at which those bacteria became resistant that was 600 per cent.

When there were residues of three antibiotics, all at the FDA "safe range" in the 10 to 100 parts per billion range, it was a 2,700 per cent increase.

(Take 1150 Follows -- Mr. Hansen continuing: Therefore, while I do agree that the amount of antibiotics that will be in the milk...)

 

(Mr. Hansen: continuing.)

Therefore, while I do agree that the amount of antibiotics that will be in the milk will be marginal compared to the overuse that is occurring in human and animal medicine, part of the way to control antibiotic resistance is through thousands of small increments, through doctors exercising restraint in prescribing antibiotics for respiratory ailments to reductions of the animal feed uses.

Since the only purpose of rBGH is to increase milk outputs, since there is no therapeutic use, we do not think we should tolerate any increase in antibiotic use whatsoever through this drug. That will be a very small step. The antibiotic resistance issue is one to which rBGH will contribute, however small, and that needs to be stopped.

In summary, I disagree with the basic notion of the report that there is no more chronic long-term toxicity testing required. I believe that there is. There are still unanswered questions. However, as I said before, I agree that there is not yet any proof that rBGH or IGF-1 is actually causing harm.

 

Mr. Pollak: I should like to clarify a few points.

First, on whether more research would be a good idea, from the perspective of a scientist, more research is always a good idea.

Second, I find myself embroiled in this issue. I am not a farmer, and I have no particular knowledge, but I am an IGF-1 scientist. The Canadian government may take some pride in the fact that Canadian research is being quoted extensively in all the reports. Many of the people who believe that BST is harmful are using our research, which was done in collaboration with people at Harvard, as proof that the product is unsafe.

The degree of confrontation is perhaps much less than one might imagine. My perspective is, especially with regard to the IGF-1 aspect of the risk, that at present there is no proof of hazard, although we understand that there are theoretical risks. The fact that there is no proof of hazard is, as has been said, not proof of safety.

The question therefore is: What do we do? That question is beyond science. It becomes a very interesting policy issue. What long-term safety issue profiles do we have for Vitamin E hand cream? What long-term safety issues do we have for baby food? What long-term safety issues do we have for carrots grown in the presence of pesticides? The issue becomes problematic for the regulatory authorities.

Do you want to set a precedent whereby the regulatory authorities will ban anything for which we do not have a long-term safety usage? Someone might want to invent a new kind of aluminium packaging for candy bars. However, if people are exposed to the residue of the aluminium for 30 years, it might be hazardous.

If you set such a precedent, you would be setting a very high standard, which you may choose to do. You may determine not to accept any product without a long-term safety profile, and you may do so for rBST and all food products, but then you open another issue in terms of your flexibility to deal with new products.

 

The Deputy Chairman: That is not the same as drinking milk three times a day. My seven-year-old granddaughter drinks milk three times a day, but she certainly does not eat three candy bars day.

 

Mr. Pollak: With respect, your granddaughter lives in a good environment and has good advice from yourself not to eat too much candy. My point is that, while I agree with you that milk is a particularly emotional substance because it is used regularly, we have not always insisted on a long-term safety profile for frequently used ingestible items.

 

Senator Spivak: Dr. Pollak, you have put your finger on the most important question, and I strongly disagree with you. You say that, because there are many dangerous substances out there, we should not apply a higher standard to a company that wishes to impose upon us a commercial product which has no therapeutic value. This raises many questions, and they are not all social and economic; they are scientific.

I believe that it raises the question because we have to make our decision on the basis of science. Is it up to the consuming public to prove that something is dangerous, or is it up to the manufacturer, in most cases, to prove that something is safe?

The EU report used a risk assessment procedure and arrived at a different conclusion than you arrive at in your report. It seems to me that that is a very logical process, particularly for something which has no therapeutic value; it only exists for commercial reasons. We might go on to the terminator gene as well, which exists for protection of investment.

When it comes to something that could prevent cancer, for example, I might be prepared to accept risk benefit. Risk management is different from risk assessment.

The EU report says that the difference between recombinant rBST and the natural growth hormone can vary by one to nine amino acids. Let us lay to rest this claim that rBST is the same as a normal compound. At least I hope you will lay it to rest.

I want to know from both Dr. Pollak and Dr. McLeod, who were on the health panel, whether you actually looked at the literature yourselves. Did you go through each piece of literature? Did you tell the Ph.D student who did the report what to look at and how to do the literature search? How did you review whatever you did review to reach your conclusion that it is fine? What methods did you use?

I understand your statement that there is no evidence, but then you concluded that because there is no evidence you did not need any more tests. I want to know what scientific method you used to arrive at that so that I, as a layperson, can evaluate what you did.

(Take 1200 follows -- Sen. Spivak continues -- Looking at this, I now understand...)

(Following Take 1150, Senator Spivak...what you are doing. TAKE 1200 begins here, Senator Spivak continues.)

**Looking at this, I now understand the value of the comment that war is too important to be left to generals. Similarly, science is too important to be left to scientists, because we do not want to be guinea pigs. You can argue until the end of time, but we do not want it forced upon us unless we know for sure. The precautionary approach is not being recognized here, namely, that if there is a dispute that something may be harmful, we should not do it -- that is, unless there is overwhelming evidence that it might be of benefit to mankind.

Having said that, I wish to know about the difference between "natural" and rBST, how you did your literature search and how you came to your conclusion.

 

Mr. Pollak: I will let Mr. McLeod answer some of those issues in regard to procedure. I will give you a hint: We had many people carrying many heavy boxes.

As far as some of the other points that you make, I have already stated this morning that my personal view, speaking as a individual, is that this product should not be approved.

 

Senator Spivak: That is not your scientific view, though.

 

Mr. Pollak: Just wait. I would not be so confrontational because I am the guy who is showing the relationship of IGF-1 to cancer. In my view, the terms of reference were: Is there proof that the product is harmful? I stand by the conclusion that there is no proof that the product is harmful. That then goes back to the health protection branch. We should ask the health protection branch how the legislation is drafted and what the responsibilities are. It is an open-ended question to prove long-term safety.

We are much closer than you think. As an individual, I do not think that this product should be approved because it serves no useful purpose. That is my personal view. If I am now asked as a scientist to prove that this is poison, or that it will cause diabetes or cancer, I am sorry but I cannot. I looked through all the literature and I understand the theory, but I am not able to reach the conclusion that this is something like diethylstilbestrol.

 

Senator Spivak: Your personal conclusion is interesting. However, when Monsanto goes to the WTO to challenge the government's non-approval, they will speak about sound science.

Is it not sound science to look at precautionary principle, to look at risk assessment and to look all of the things that are contained in the EU report about risk assessment as well as risk benefit? I am asking you as a scientist.

 

Mr. Pollak: Of course it is.

 

Senator Spivak: Let me see if I have this straight. I believe this is at the crux of the issue that we are dealing with and it is not just the little trivialities.

As a scientist, why did you not say to the government, "Your terms of reference are inadequate because we should be looking at risk assessment rather than risk benefit or whether we can prove harm." Why did you not ask that scientifically, and not because of your personal opinions?

 

Mr. Pollak: We did the job that we were told to do.

 

Senator Spivak: That is what they said with the Manhattan project.

 

Mr. McLeod: That is worse than the alcohol metaphor.

 

Senator Hays: You should give them a chance to answer, Senator Spivak.

 

Mr. McLeod: Senator Spivak is, as she says, into the crux of the matter here. I come from McMaster, which is the mothership of evidence-based medicine. My colleagues at McMaster are famous for promoting evidence-based medicine all over the world. We do that on the basis of scientific evidence.

Even the most extreme zealot for evidence-based medicine will admit that there is a point where evidence meets societal values or human values, or whatever. That is where we are with this. I believe that the scientific evidence that exists on this point of human risk meets all the normal standards for scientific evidence. Science does not deal in absolutes. I think I said this the last time I was here. We deal in probabilities. You deal with 95 per cent levels of probability or 99 per cent levels of probability or 99.9 per cent levels of probability, et cetera. In the opinion of our panel, the probability, based on what we know today, is that giving rBST to dairy herds in Canada will not pose a human risk. That does not mean, as Mr. Pollak has said, that we are endorsing rBST or promoting its use. It simply means that we do not believe that there is a scientific standard that would allow you to reject this on the basis of scientific study.

We are in total agreement with Mr. Hansen is saying about the need for more research. This is an important issue, namely, the effect of the insulin growth factor and growth hormones. People will go on researching this for the rest of time. None of us would want to stop that. However, we were asked a question that relates to the Food and Drug Act. We read all the time that Canada operates under the rule of law. We are the law in this country which says how you get a product licensed. It states that you prove that the product is of good quality and that it is efficacious. No one has questioned either of those things in relationship to this product.

The only remaining question is whether or not it is safe. That is a tricky issue because it is a product that is administered to cows that has some implications for human health. That is the issue that we dealt with on our panel.

 

The Deputy Chairman: I do not remember the exact wording in the act, but my interpretation is that if there is any doubt about human health, you should not approve it. Perhaps Mr. McLeod has a different interpretation than I have, but that is the ordinary layman's interpretation of that act.

 

Mr. McLeod: I do not believe we have any difference of opinion. There is a scientific standard of what constitutes doubt. As scientists, Mr. Pollak and I deal with those probabilities. That is the basis on which our committee looked at this.

 

Senator Spivak: I should like to return to this issue later.

 

Mr. McLeod: I wish to respond briefly to the senator's question about process. Senator Spivak asked us who reviewed the literature. We had six members of the panel. We are quite different individuals, as you can see from listening to Dr. Pollak and myself. We have different areas of expertise. We all read a wide variety of papers. We were given 10 or 11 volumes of papers by Health Canada that came from the Monsanto submission. We had no shortage of information. We had a research assistant who did an extensive search at the request of the members of the committee. She brought additional materials to the panel. It would be disingenuous of me to suggest that we all read everything that has been written about this subject. In the last 12 months alone, there are at least 1,000 papers on IGF-1 in the literature. None of us have the time to read those papers. We did the best we could in the time available. The research process was not guided by a research assistant hired for the purpose, it was guided by the members of the panel.

 

The Deputy Chairman: Mr. Pollak, you spoke about antibiotics, and so on. About two years ago, in eastern Ontario, a large tank load of milk was transported to a cheese factory. It was supposed to be sent to a fluid milk factory. They could not make cheese out of it because it contained too many antibiotics. After farmers treat their cows with penicillin or any antibiotic, they are not supposed to sell the milk from that cow for so many days. The milk was traced back to the farmer and he had to pay a big fine. Antibiotics were certainly found in the milk and they caused problems in that they would not allow the bacteria to work to make the cheese.

(TAKE 1210 follows, The Deputy continues: That would have gone through the pasturization system...)

RC/Agriculture 34842/April 26/99

(The Deputy Chairman: continuing.)

**That would have gone through the pasteurization system into the food market, after which children and other people would have consumed the product.

 

Senator Chalifoux: We have been hearing about the pros and cons of many reports. In your deliberations, did you take into consideration some of the reports that have been brought before our committee?

Did you read and take into consideration the report from this committee in your deliberations?

I believe the EU report is very important for your consideration. Did you consider that?

You also stated that there were volumes of papers from Monsanto that you went through. How many volumes of other papers did you consider when you were looking at this matter?

 

Mr. McLeod: To take the last point first, senator, you may have misunderstood me. Much of the material that we received from Health Canada or from the Bureau of Veterinary Drugs was part of the Monsanto submission to Health Canada. We had no direct communication with Monsanto at any time during the meetings of our committee.

As for the other reports, our report came out in January 1999. Clearly, we did not have the benefit of seeing either the report from this committee or the one from the European Union, although we have subsequently seen them.

To return to the point raised by Dr. Chopra earlier, clearly, our committee was not asked in any way to comment, nor would it have been appropriate for us, on the process at Health Canada. If that were the issue, then we should have interviewed individuals from Health Canada. We should have learned a great deal more about the process as it exists. We were asked very specific, scientific questions about our perception of the risk associated with rBST. That is what we answered.

If Health Canada or any other agency wishes to come back to ask us to look at the process issues within the Bureau of Veterinary Drugs or the Health Protection Branch, that could be done. However, that was not our charge last year. I cannot apologize for not addressing those issues. Indeed, it is a very complex issue that deals with values and many other things that go well beyond the science at which we were looking at.

(French follows -- Senator Fernand Robichaud)

(après anglais)

 

Le sénateur Robichaud: Vous dites qu’il n’y a pas vraiment de raisons d’utiliser cette hormone de croissance. Cependant, il y a des gens qui veulent l’utiliser. De notre côté, on ne veut pas dire qu’elle ne doit pas être utilisée parce qu’elle n’ajoute pas grand-chose et qu’il existe d’autres façons de produire plus de lait. On aimerait avoir une base scientifique pour dire qu’on n’a pas besoin de cette hormone.

Votre rapport indique qu’il n’y a pas de danger pour la santé humaine, mais ce matin, vous nous dites tous les deux qu’on ne devrait pas l’approuver. Dans les conclusions de votre rapport aux paragraphes a) et b) de la version française -- au paragraphe e) de la version anglaise -- vous dites qu’il est nécessaire de réaliser une étude plus approfondie pour expliquer si la réaction immunitaire observée est importante en association avec de très faibles concentrations telles qu’on peut les observer dans le lait de vache. À la recomandation c), votre comité est d’avis que la question de réaction d’hypersensibilité suite à des doses chroniques nécessite un éclaircissement. En conclusion, vous avez quatre recommandations dont deux disent qu’on a besoin de plus d’information. À ce moment, n’aurait-il pas été préférable de ne pas recommander l’utilisation de cette hormone ou de dire que ce produit peut être utilisé sans avoir des effets sur l’être humain? Je suis un peu confus. Est-ce que vous pouvez m’éclairer?

(Mr. McLeod : Our committee was not asked to judge wether or not…)

(anglais suit)

(Following French)

 

Mr. McLeod: First, our committee was not asked to judge whether or not this product should be approved for marketing and given a notice of compliance. We were asked to respond to some specific questions about possible human risks that had been raised by scientists within the Health Protection Branch and the Bureau of Veterinary Drugs. Our response was that, by and large, the kinds of studies that had been suggested in what was called the gaps analysis were not required. It is difficult to imagine why you would want someone to do a long-term study of rBST given that the hormone is species specific. Since it only works on cows, you cannot reasonably do a long-term toxicity study in some other animal model.

There was also a veterinary panel looking at the question of safety in animals. Therefore, from the point of view of human safety, there was no reason to recommend these longer-term studies.

We were concerned about IGF-1. We advocate continuing research on IGF-1, as we have said.

The one issue that came out in the discussion which seemed to possibly have some implications for human safety was this report of an allergic or an immune reaction to BST when it was given to rats. We thought that deserved clarification.

In its submission, the company suggested that the response that was seen at a low dose was, in fact, a laboratory error, or that it had been caused by the mislabelling of a sample or something of that sort. That may well be true. However, when the company was first aware of that, they probably should have repeated the study. That would have made some sense.

What we were saying is that we would agree that that should be clarified before one gives this product a clean bill of health.

Beyond that, I do not see the confusion.

 

Senator Robichaud: You just said it should be reviewed before it is given a clean bill of health. Yet you have as a committee of experts given it a clean bill of health.

 

Mr. McLeod: No, we said there was one area that required further clarification before a notice of compliance could be issued. It is possible that that could be straightened out. I am not sure that it even requires a further period of experimentation. It is possible that the scientists from Monsanto could sit down with Dr. Chopra's colleagues at the Bureau of Veterinary Drugs and explain these results, although I rather expect not. From the history of this, they probably will have to repeat the study. That was our recommendation.

We did not feel that there was a need for other kinds of long-term toxicity studies.

(Take 1220 follows: Mr. Chopra: Thank you Mr. Deputy Chairman...)

 

 

Mr. Chopra: Thank you, Mr. Deputy chairman. I am sorry I got too far into science and too far into politics. However, both are related here.

As a scientist, I can say that any committee must look at what is available. Dr. Hansen has a letter that he was reading from earlier, from Dr. McLeod to the Toronto Food Policy Council, in which he indicated what he received and what his committee reviewed. In there, he indicates that he received the gaps analysis report, but the edited version. You also received an edited report and you demanded a full report. Similarly, I do not know how much editing was done from the gaps analysis that was given to Dr. McLeod's committee, but he admits that he received an edited version.

 

Mr. McLeod: May I interject?

 

Mr. Chopra: May I continue?

 

Mr. McLeod: I could correct this misunderstanding, if you wish.

 

The Deputy Chairman: If you would, let him finish, because this is all recorded.

 

Mr. Chopra: The point is it is not just the report, but what comes next. Dr. McLeod's committee came to Ottawa when they received their mandate, and they met with the department officials. Dr. Yong was there, Dr. Landry was there, Dr. Alexander was there, Dr. Paterson was there. Everyone was there except the people who wrote the gaps analysis report. To a scientist, that raises some questions. Since there is a conflict of opinion -- never mind the personalities here, never mind the process here, never mind that they have been asked not to comment on this -- should they not want to talk with us? Dr. McLeod is suggesting that there is no need for further studies, and that maybe we could sit down with Monsanto and work this out. We have been dealing with Monsanto for 10 years and we have not been able to work it out.

On the immunological report, I must add that this is not the first time that this happened. In 1988, it was already known that BST could go through the rat's mucus membrane, and it was suggested, before it was developed, that this could happen, and Monsanto knew that they should study it. Then, when they studied it, they confirmed that it happened. That does require a long-term study.

Dr. McLeod's committee are medical experts. They know that there is antibiotic resistance, a very serious problem. He mentions only the allergy, and he has again confirmed -- and that is the point that I was trying to get into -- that the whole world, the World Health Organization, everyone, is screaming about the serious danger from antibiotic resistance coming out of the animals to humans. People are dying as a result, and great care must be taken. Even the later, post-approval monitoring studies in the United States have shown that there is at least a 25 per cent increase in mastitis in cows, which needs to be treated with antibiotics. It is not a question of residues any more; it is a question of additional use of antibiotics, which poses a danger.

The question has been also raised, which is at the interface of science and politics, of what is called risk analysis and risk management. The point has been made by everyone, quite eloquently, that this is a political question that someone else must address. We scientists in Health Canada are not allowed to address that question, but, as you heard before, in Australia and New Zealand, the scientists can. In Canada, we are not allowed to. I have written a paper on risk analysis and risk management, as the department official, to the risk management committee in Health Canada, because now they are moving on to this new transition thing. My recommendation was that when the motivation is profit, then we must also manage by curtailment or by taking precautions which will be also economic. We are not talking about individual people being hurt in this process; we are now talking about population toxicology. We are not talking about an individual getting an adverse reaction; we are talking about the entire population, and we do not know what will happen to it in 10, 15, or 20 years from now. Those points have been made. If that is to happen, will we have a situation, such as with cigarettes, where the governments are now suing the companies to get money, or should we not be taking an approach at this time whereby we say that the companies who are asking us to take risk as a public should be buying insurance policy?

We all take risks in life. We ride on airplanes and on trains, but everyone carries an insurance policy. Even in their own homes, people require a fire insurance policy. You will not get a mortgage without it. Similarly, if the companies make money and nothing happens, then fine, they keep all the money, but if something happens, someone will have to pay for it and it should not be the public.

 

The Deputy Chairman: We all know there is a section of the Health Act about those making the decision -- I mentioned it some time ago -- which says that, if they have any doubt concerning the product, their duty is not to approve it.

 

Mr. Chopra: You are absolutely correct, senator. I do not have the exact wording but that is what the Food and Drugs Act states. All information will be released and made available to the government for its assessment. As you know, the Food and Drugs Act comes under the Criminal Code. It is a criminal offence to hide any information, whether it is a company or a government official or anyone else. It is a criminal offence.

 

Mr. McLeod: On the question of the edited version of the gaps analysis report, that may have been the word I used in a letter to the Metro Toronto Food Council but the editing consisted of blacking out some names because there was dissension at Health Canada. I guess those who were sending the report felt some duty to protect the privacy of the individuals at Health Canada. There was no scientific editing of the report.

 

The Deputy Chairman: You are more fortunate than we were. The first one we received had much of it blacked out.

 

Mr. McLeod: We received different versions at different times, but when we had our first meeting last July, we were told about the report, and within a week or ten days thereafter, we received it. My recollection is that the only editing was of names.

 

Senator Hays: As other senators have mentioned, I, too, am confused on the scientific side of this issue, which is more debate than inquiry. I would add as a preface to my question that the issue of whether or not we use this performance-enhancing product does have some economic consequence. Canada has entered into some international agreements which may take the decision as to whether or not the product is used here out of our sovereign hands, if we have no good reason not to allow it to be used. In your comments, Dr. Pollak, you stopped short of that. As a scientist, you have a point of view. In terms of what will happen, if there is no reason for us not to allow this certificate of compliance to go ahead, then there may be trade remedies which would have the result that it would go ahead anyway.

There are also other implications, in that we do not have trade in the product, milk, which would be affected by not using it in Canada, but at some point in time we may, and if we did, we would be at a comparative disadvantage when competing with producers of the product who did use it.

As another aside, I am not a scientist at all and have no background in that area, but the thing that never gets mentioned, and about which, as a non-scientist, I am very curious, is the fact that we have a long history of consumption of milk produced with this performance enhancer.

(take 1230 follows, Senator Hays continuing: In other cases where there have been adverse consequences...)

 

MA April 26, 1999 34842 Agriculture

(tk 1220 ends--Senator Hays: continuing…with this performance enhancer.)

In other cases where there have been adverse consequences, they have shown up in the epidemiological result in terms of their effects on people. In the case of milk and effects over a long period of time, there does not seem to be any attention given nor any research coming out on it.

A comment on those things would be welcomed, or not, as you see fit.

The real question is, how do we resolve this issue? As minority politicians, when something is happening that we do not like, we filibuster or we try to rag it around until it dies or something happens or it goes away. Sometimes it does not go away and someone must break the impasse by finding a procedure which will achieve the desired purpose.

I gather that, in the Health Protection Branch, procedures are being followed to refer the issue to the panels. Two of you here today represent those panels. Dr. Chopra represents the initial work. Dr. Hansen has interesting observations from a consumer point of view.

How do we get to the end of this, or are we at the end now? Is this a good way to run a railroad? Is this the best way to resolve differences between scientists which inevitably occur and which are profound and deep and some of which in the end -- and this may be one of those examples -- are irreconcilable?

Disputes can be motivated by true science. At least two of you have hinted that this dispute is motivated other motives. You say you think it is a good idea, where profit is involved, to have other things accompanying the examination which are really outside of the scientific question.

How do we bring this to an end? Is this a good procedure? Do you have some ideas on what we might say in our report that could help the Health Protection Branch? Based on this interesting experience, can we come up with a procedure, a process, which will be fair to all concerned, to the users of the product, to the makers and so on? Can we be satisfied in cases where everyone cannot agree that we have done everything we possibly can to ensure a good decision is made on whether this product is available or not?

 

Mr. Pollak: I can understand, particularly from the viewpoint that there is no apparent reason to proceed because we have enough milk without this product. As I have stated, I have some sympathy to the view that there is no reason to approve this product.

In a technical sense, I feel that the Government of Canada or the Health Protection Branch might have difficulty in demonstrating proof that the product is hazardous, notwithstanding the concerns. Therefore, based on the legislation -- and I am not a lawyer -- you may choose to find a political way to disapprove the product because you have concerns.

As a committee member, I would have loved to cite an epidemiological study where, in differing states of the United States, patterns of BST usage varied. If we could have found out from the Colorectal Cancer Institute that the colorectal cancer rates varied, too, and if we had epidemiological data that demonstrated a clear risk, then it would have been our privilege and our duty and I would have zealously said: We have got it. We have fingered it. It is dangerous. People are dying. We have proof. Do not allow it.

We did not have that kind of data. If you do not want the product in Canada, and I am sympathetic to that, you must find a way to express your concerns that the product is not in society's interests, rather than saying the product is disallowed because of some black-and-white proof. You have no proof that it causes cancer. What you have are concerns. You have reasonable concerns. If you feel that under the law we should not license products for which you have concerns, then there is a legislative solution for you.

That is where you are. The actual smoking gun that would allow us to disallow the product on technical grounds is not there. You have heard my colleague from the consumers' group in the United States. We are worried but we do not have proof, so then it becomes a legislative issue. If we are worried about a product, does the law allow us to disallow it? If so, just apply the law.

The only issue is that some companies, for which I have no affiliation and sympathy, might say that they have rights, too; that this is a free country and they can sell something if they choose. They can sell tobacco or alcohol or rBST.

How do you deal with those people who say they have a right to sell this product; that this is not a totalitarian state so you cannot interfere with their rights and freedoms? This is how it boils down.

 

Senator Hays: I do not wish to debate with someone who knows much more about a subject than I. However, when you put the tennis ball back on this non-scientific side of the court, we have tied our hands with agreements. The use of growth hormone in beef production is an example. The European political concern is that there may be something wrong with it. We are not sure but, out of an abundance of caution, we will not allow that product to come in.

There are other issues here. Is it a non-tariff trade barrier and so on?

As we see that play out more fully, it is possible that even though they have the concern and the political will, having become a signatory to a multilateral trade agreement, they may no longer have the ability to make a political decision such as that. I point that out.

 

Mr. Pollak: I recognize the depth of the problem.

 

Senator Hays: It is not so simple to put it back in our court because we will ultimately send it back there, as the Europeans have done. They have until May 13 of this year to do some studies to find out if it is bad for humans and if there is a good scientific or health reason not to allow the product.

 

Mr. Pollak: I recognize that everyone's job would be much simpler if we could have discovered black-and-white proof of non-safety. It would have been made everyone's job easier. Then it would be a clear-cut case.

I was unable to find such proof. I apologize that the situation is so complex, but as a scientist, even if I yearn for a simple answer, I cannot fabricate a simple answer if the truth is complex.

 

Senator Hays: How do we then bring this argument to an end among the scientists?

 

Mr. Chopra: Mr. Chairman, if I may comment not only as a scientist but as a scientific regulator speaking to the legislators, I would say this: Before 1906, there was no Food and Drugs Act in the United States or in Canada. At that time there was an act called the Adulteration Act. If the product was pure, that is all anyone needed to know. In those days, people mixed turpentine and alcohol and all kinds of things and sold them as potions.

When purer drugs came on line, the government said a drug must be pure to be sold. Then in 1938, some people mixed two pure products and killed about 40 Americans. That occurrence sparked the beginning of the Food and Drugs Act in the United States and Canada.

Around 1946, we had a revision which led to our Canadian Food and Drugs Act. That act required demonstration ahead of time by toxicological evaluations and experiments in animals.. That is where it began. Study was required on two species of animals and so forth and all those regulations were put in place.

We went along quite happily for another couple of decades until thalidomide. No one could foresee that, by doing toxicology in adult animals, you were forgetting the embryos. Only in retrospect we found that those studies had to be done and a new revision of the Food and Drugs Act occurred in 1967 in Canada as a result of what happened in 1962.

(tk 1240 follows--Dr. Chopra cont…We are now at a stage where we are talking about not)

34842/Agriculture/April 26, 1999/DM

(Mr. Chopra: continuing -- of what happened in 1962)

We are now at a stage where we are talking about not toxicology of whole people or embryos, but toxicology of individual cells of the corporate bodies into the future, whole populations. In our report, the gaps analysis, when we talked about infertility and sterility and cancer, those were the concerns we were raising. We do not need to provide proof, because if you were to provide proof ahead of time, the thalidomide situation would not have happened or it would have continued to happen.

I am emphasizing as a scientific regulator that those are the issues now before us. You are looking at the entire population. Children, pregnant women, and old people will be consuming, and they are not making any choice. Labeling does not help. You are talking into the future. Dr. Pollak is absolutely right when he says that if he had epidemiological proof, then we would not need him. As a scientific regulator, I would say there is proof here.

 

Senator Hays: Let me come back to this. That is interesting and helpful background. One solution always is, "Let me decide, and do not listen to those other people." I do not think that is a good idea. How do we best resolve the differences between you four? For example, processes are in place now of references to independent panels which you cannot get in-house. We have this interesting issue of management and actual research and differences within Health Protection Branch and so on and so forth.

We have moved ahead on this, and there have been attempts to resolve the issue; however, it still has not come to an end, or perhaps it has. If it has come to an end, it is not a satisfactory one. I am looking for comment on how to do a better job of bringing these differences to bear.

 

Mr. Pollak: In point of fact, the four of us here are not really disagreeing on the actual scientific data. The science takes us so far, and maybe the scientists are having trouble because we are getting out of our domain. As has been said by others, we have no proof of danger, but we also have no proof of long-term safety. That is a difficult report. I think we have a consensus. I do not think any of us feels that there is actually proof that this is dangerous.

The question, then, is not that there is a scientific, technical issues to resolve, but an issue of how is society best to deal with a risk that is believed to be low but not eliminated. One point of view says let us be careful and not allow that stuff. Perhaps that is the right point of view. Then it will be done under the terms of the legislation where it is risk avoidance rather than censoring a toxic product.

I would like to make one last point. This has become international. My phone does not stop ringing. There is the Europeans, and there is the Americans, and the Canadians may turn out to be a tie breaker. It is a big agenda, and I am sorry to say it is not just about rBST. It is a precedent-setting case. There will be more about it.

Perhaps this committee should seriously explore the possibility of Canada taking a leadership role and getting people together on a global basis. We should not say that this is a little BST issue and we need to find a technical solution. The big problem is, as Dr. Chopra has said, how to modernize our global risk management policies for regulating foods and drugs. I think the FDA may have a little egg on its face because all of us have shown that they perhaps overlooked some facts that they should have at least commented on. Perhaps we in Canada could bring together regulators or interested parties from the U.S. and Europe and say, "Listen, this is a new issue. Perhaps our old, simple, historical view is very useful, but it is no longer just a matter of ensuring that they do not put turpentine in the meat. It is no longer as simple as the old-fashioned adulteration."

I think we could take a leadership role. You have put your finger on the fact. It is not just as if we need to find the right piece to fix the jigsaw puzzle. In your committee, we are recognizing that this is actually a new kind of jigsaw puzzle. It is not this committee's problem, or just a BST problem, or a Canadian problem; it is a global problem about managing our food supply.

If we were able to solve this and find the trick that you are looking for as to how to deal with it effectively, we would not have just solved the Canadian BST regulatory problem but also the huge issue of how to integrate biotechnology and agriculture globally. It is a much larger agenda than the specific issue that has brought us here.

I would recommend that we show some leadership.

 

Senator Hays: That is a good suggestion.

 

The Deputy Chairman: Dr. Pollak, we think we in this committee have already shown some leadership.

 

Mr. Pollak: Take it further. I congratulate you. I recognize that you have.

 

Senator Hays: Let us put JECFA and Codex and the Alimentarius into context here. The more players we bring to the table, we will still have the same problem with this agreement.

I will stop there.

 

Mr. Pollak: I should let someone else answer.

 

The Deputy Chairman: I want to say to the two people, one from McGill and one from McMaster, that over a year ago I wrote all the important universities that I knew of that were doing research on agriculture. Two of them told me to mind my business and about 100 per cent subsidy operated organizations, et cetera. I did not like that very much. Some of them called me and said, "We cannot tell how you how many we turned down because we did not like what was being done because the strings are attached to the research project." Research is not independent like it should be. It is not independent like it was.

We talk about our good scientists, and so did Dr. Von Meyer. We are not giving them the freedom to be those good scientists that we want them to be. As he said, we should give them some more funds. He talked about Dr. Dosch in Toronto who did the work on diabetes.

 

Senator Hays: Two other witnesses wanted to comment. If possible, I would like to hear them.

 

The Deputy Chairman: I thought I was chairman.

 

Senator Hays: You are, but sometimes you have to listen to your members of your committee as well.

 

The Deputy Chairman: I have probably chaired as many committees as anyone in this room, and some of them an agriculture committee with 45 members, 44 including the chairman, and a minority chairman at that stage of the game.

Senator Spivak, you wanted to ask a supplementary about 20 minutes ago.

 

Senator Hays: I take it you are not going to allow them to comment?

 

The Deputy Chairman: You can take whatever you want, but I will say who speaks first.

 

Senator Spivak: I am happy to have them comment before I ask my questions.

 

Mr. McLeod: Briefly, I think Dr. Pollak, as he does, is driving us towards the real issue here. The difficulty is that we are talking about apples and oranges.

When we talk about the Food and Drug Act and the regulation of pharmaceutical products, whether for animal use or human use, we are talking about an internationally accepted scientific standard. In fact, in spite of the impression you may get from the discussion, it is quite well documented and quite well understood. There are standards of safety, and they are scientific standards of probability that are generated by methods that are well recognized.

(1250 follows -- We do have an international conference)

(Take 1250 Begins -- Mr. McLeod continuing)

We do have an international conference on harmonization that is looking at this. There is not much disagreement between the European Community and the FDA and the Japanese government, or Canada and Australia. There is debate, however, we will probably, in the near future, have an international standard on drug evaluation. It will not solve the problem of rBST because, at the end of the day, by the scientific evaluation, almost inevitably the conclusion will be that there is no proof of danger.

That does not mean that it is absolutely safe. It does mean that given current methods it is impossible to prove danger. You must contrast that with all sorts of other products, as Dr. Pollak has pointed out, that are in common use that are known to be dangerous. We cannot apply an unfair standard to bovine growth hormone or to other similar biotechnology products.

That said, there is a huge challenge which is to deal with this question of risk analysis. I believe you started to get at that in the report of this committee that came out last month. You talked about the precautionary principle and that sort of thing. That is what it is about. That is where values come in. How much risk are you willing to accept for a product that, as Senator Spivak says, has no therapeutic value. We do accept risk every time we use penicillin. We know it is life saving, we also know it kills people, however, we accept that risk because there is a huge benefit. In the case of bovine growth hormone, we would all agree that there is no substantial gain to Canadian society in using it, other than economic, and there might even be some debate about that. It does change the equation. However, the issue turns around societal values, not around the science of drug safety, in my opinion.

 

Mr. Hansen: I would disagree with some of that. I do agree that there is no proof, however, if you look at the questions that were posed to the panel they were not is their proof. It is all this is there a potential effects or risk. The executive summary that came out said that there is no biologically plausible mechanism. That is the quote that Monsanto used all over the place. Of course, there is a biologically plausible mechanism. The fact of the matter is we do not have enough data, therefore, I do not know why the panel did not come out and say that there is a potential problem, we did not say how large it is because we do not know exactly how much IGF-1 is in the milk since these other questions have not been answered. We need to answer those before we can quantify the risk.

The questions that are asked is are there potential things. To turn the question around and to try to say that you are asking for proof, none of the critics came in and said we have proof that there is a problem here. When you do not approve a pesticide or some other drug, it is not because you have proof that it is causing cancer or some other effect. It is if there are effects in laboratory animals in the regulatory process they can decide not to approve it.

The problem I have with this report is this has been used by Monsanto all over the place and they wave it around and say these people said there is no biologically plausible mechanism, and that is simply not true.

 

Mr. McLeod: That is not what it says. It says that no biologically plausible reason for concern about human safety if rBST were to be approved for sale in Canada.

 

Mr. Hansen: That is what it says in the executive summary and that gets pulled out of context. However, when you start looking in your conclusions and we see that the panel recognizes major difficulties in drawing inferences about the potential for indirect human toxicity related to the increased production of IGF-1 and rBST treated animals. The medical and scientific understanding of IGF-1 will undoubtedly continue to grow. However, the panel does not believe at this time that there is a significant probability of increased human toxicity resulting from the very small increments in IGF-1 concentration observed in the milk and other products from rBST treated cows.

That is not saying there is no biologically plausible method, they are saying that from what we know right now, from the levels that are in the milk, and you are accepting data that you did not look at very carefully. Look at your table of ranges for IGF-1 values in milk. That is not what is in the original articles.

 

Mr. McLeod: You understand that words can be taken out of context by both sides of this argument. I believe what our panel was stating very clearly was that the evidence that is available today does not meet the accepted standards of scientific proof that there is danger. That is what our Food and Drug Act requires.

 

Mr. Hansen: That is not what was asked.

 

Senator Spivak: Let us get to the micro level, not the macro level, for a moment.

You see, scientifically, we are not talking here about emotion or political opinion or anything like that. The EU panel said:

Risk characterization has pointed to an association between circulating IGF levels and an increased risk of breast and prostate cancer, and in addition the possible contribution of life span exposure towards dietary IGF-1 and related proteins present in milk from rBST cows to gut basophysiology, particularly at the incidence and to gut associated cancers need to be evaluated. The available data exposure for exposure assessment...

Et cetera. It is incomplete. The question was do we need more studies. They came to the conclusion that yes, based on science, not on political opinion. Your panel, the health external panel, said, no, we do not need any.

 

Senator Robichaud: In two recommendations they did.

 

Senator Spivak: On two recommendations you did, however, the general impression is that we do not need any.

You speak, Dr. Pollak, of risk management. That is entirely different from risk assessment. It seems to me that scientifically you need to decide, not politically, on things that can affect populations and on things like hormone mimicking chemicals and others, whether you will use risk management or risk assessment. That is what I asked you in the beginning. It seems to me it is not appropriate to use risk management if you are looking at things like this until you look at risk assessment.

Again, just because there are hundreds of dangerous chemicals out there, does not mean that we should not apply standards of risk assessment to things which are produced for commercial reasons. The reason I say that is because that is an increasing tendency. It was not available previously. Now you have these huge companies that are going into life sciences and they are targeting all kinds of things for commercial reasons, which are drugs, right?

We need to look at this scientifically, first and foremost, not politically. The question I am asking you is, given your scientific opinion as to whether we need longer studies, what is your view of what the European Union suggested?

 

Mr. Pollak: The European Union, with modesty, the section is based on my work, or the work of myself and my colleagues.

 

Senator Spivak: Their conclusion is different.

 

Mr. Pollak: Their statement also obviously was drafted with care. There is no doubt in my mind that there is a relationship between the serum IGF level and cancer risk. They do not say that there is a relationship between bovine somatotropin and serum IGF-1.

 

Senator Spivak: They do not, however, they say it needs to be looked at further.

 

Mr. Pollak: I agree that it needs to be looked at further.

 

Senator Spivak: That is all the committee asked. Our committee report did not say there is a danger in rBST. We said there is enough evidence to suggest that we need to look at this further.

 

Mr. McLeod: We all agree with that, I believe.

 

Senator Spivak: Would you say that that should be the conclusion?

 

Mr. McLeod: No one questions the need for more research.

 

Senator Spivak: Are you suggesting that your report, properly interpreted, would lead toward further study?

 

Mr. McLeod: I believe the distinction that I would make on the report is that our report relates to the obligations of Monsanto under the Food and Drug Act. Our conclusion was that the information that is available now meets the standards of the Food and Drug Act. Dr. Chopra may disagree, or Health Canada may disagree, however, our advice to Health Canada was that they meet that standard. That does not mean that they meet the scientific standard for all time or that we will never need to know more about this; quite the contrary.

(Take 1300 follows -- Senator Spivak next speaker: That is an interesting observation...)

 

 

Senator Spivak: That is an interesting observation. My understanding is that there is a data package which is standard operating procedure, and that includes all sorts of things that Monsanto has never done. They were asked to do that long ago and they did not do that. There is something amiss here; not from any political or economic standpoint, but from a scientific standpoint. They did not even do the minimum.

 

Mr. McLeod: Our panel would disagree with you on that. We did look at the gaps analysis and decided that most of those gaps were unimportant.

 

The Deputy Chairman: Before I came to the Senate, I lobbied against Monsanto. I was probably the only lobbyist who did so, and I was paid only a minimum fee for it. I did so because I believed that they did not do enough research. Monsanto has used your report in a glorious fashion, saying, in essence, that they got a clear bill of health. There is no way you could get a clear bill of health on that.

One of your colleagues said that I am against biotechnology. I was responsible for spending more of your money on research than any other company in Canada. We developed a lot of good biotechnology.

Archer Daniels Midland is saying that they cannot ship our corn or soybeans to Europe. They will only take that which we swear by affidavit has not been genetically modified.

In Western Canada, we are developing weeds out of canola because Round-Up will not kill them. The seeds fall on the ground and we are developing another weed. If your neighbour uses it and you do not want it in your plant, you will get it anyway, because the bees will spread it.

When I wanted to go to Codex I was not allowed, because I am not a scientist. I have spoken at scientific meetings all over the world.

I do not understand how universities that get their money from big companies can be independent. I am worried about what is happening in that regard. In some areas, 80 per cent of our crops are genetically modified.

 

Mr. Chopra: Dr. McLeod said that there is no disagreement on this side of the table. It is fair to say that there is absolutely no disagreement between Dr. Pollak and I, but there is disagreement between Dr. McLeod and I. Dr. Pollak said that if he had the benefit of another 15 or 20 years of epidemiological data, he would be able to say which way we should go. I said that if we had that data, we would not need Dr. Pollak. I, as a regulator, with his science, would be able to make a decision.

On the one hand, Dr. McLeod is saying that more research is needed. On the other hand, he is saying it is not needed. I find it very difficult to understand how he can say that the Food and Drugs Act has been satisfied by Monsanto. I think he is wrong, because there are very specific requirements in the Food and Drugs Act with regard to what toxicology studies are required, and they have not been done.

I see disagreement between the two panellists sitting here. One wants more data the other says that everything has been done. From my point of view as a regulator, I am getting different messages from the same panel.

 

Mr. McLeod: I am certain that there is no real disagreement between Dr. Pollak and myself. One must make the distinction between more data being required about insulin growth factor 1 -- which is the real issue here, which is the risk factor -- and more data being required about recombinant bovine growth hormone. Our panel simply said that, in our opinion, there was no rationale for asking the sponsor of this product to do more studies on recombinant bovine somatotropin. We all agree that we would like to know more about insulin growth factor, and we will know more about it. It is, however, clearly not the responsibility of Monsanto to do that work. It may be the responsibility of the Medical Research Council, the national institutes of health, or the equivalents in the European Union, but it is really only very indirectly related to this product. I do not think there is any lack of clarity in the position of our panel on that.

 

Senator Spivak: Except that we do not know what the introduction of rBST does to the levels of IGF-1.

 

Mr. McLeod: With respect, we have quite a lot of information. We know that it causes marginal differences in insulin growth factor, but they are marginal compared to the endogenous insulin growth factor that we are all producing. That was the conclusion of our panel; not that insulin growth factor is unimportant, just that rBST is not an important factor in determining how much insulin growth factor you will be exposed to.

 

Senator Spivak: What is the relationship? After all, rBST is not the same as the naturally occurring BST.

 

Mr. McLeod: It may differ by an amino acid or two.

 

Senator Spivak: Up to nine, they say.

 

Mr. McLeod: There are several different recombinant growth hormones that have been submitted in the past for approval to Health Canada and other agencies. The only one left on the table is the Monsanto product, but there are other growth hormones. However, they are species specific. Bovine growth hormone does not have effects in humans, other than this possible allergic response which some may bring out as evidence that it is not biologically inactive. Again, they are splitting hairs. It is biologically inactive in the sense that it has no receptor to interact with.

 

Senator Chalifoux: How can you make that statement, Dr. McLeod, when we have received reports that it needs more investigation and research? You cannot make a blanket statement that there is nothing wrong, because not enough research has been done and there is not enough knowledge.

 

Mr. McLeod: I am not quite sure what you are reacting to, but there is a great amount of research being done.

 

Senator Chalifoux: It is being done; it has not been done. I am reacting to your statement that there is no evidence to prove that there is something wrong. There is no evidence for the simple reason that there has been no research done. More research must be done.

I have been listening to this all morning, and I am amazed. I have read your report. In one place you say that nothing further needs to be done. In another place you recommend some clarification -- not research; clarification. That must be addressed.

We are not talking about the world market; we are not talking about world research or standards. We are talking about how this affects humans, and not enough research is being done. That is my conclusion as a layperson.

 

Mr. McLeod: Clearly, I have not succeeded in making you aware of the distinction between bovine growth hormone and insulin growth factor. They are two different things.

 

Senator Chalifoux: However, it needs to be researched.

 

Mr. McLeod: There is need for ongoing research on insulin growth factor.

 

Senator Spivak: On this point, in the EU report they say that whether the use of rBST will modify the level of risk remains to be substantiated. That is the question.

 

Mr. McLeod: You could say that about virtually every product that is approved for sale in Canada today, senator.

(Take 1310 follows -- That does not distinguish this product from other...)

Victoria Aucoin /April 26, 1999/AGRICULTURE #34842

(Following Take 1300, Mr. McLeod, in Canada today. TAKE 1310 begins, Mr. McLeod continues)

**That does not distinguish this product from other products. Every drug that is approved for licence in this country comes with the same caveat.

 

Senator Spivak: However, you are dealing with hormones.

 

Mr. McLeod: Many of the drugs that we use routinely in medicine are a great deal more dangerous than this one.

 

Senator Spivak: We are really in trouble, then.

 

Mr. McLeod: No, we are not in trouble. It is part of the scientific process. We study these things.

 

Mr. Von Meyer: I am trying to get my heart down so that I can talk to everyone.

Mr. McLeod, your report ignored the only report done in the world done on the biochemistry of whole BST milk fed to rats, which was conducted at Guelph. They showed a statistically significant effect on liver weight in that report. When they tested BST, in a separate set of data, and the effect of BST injection on fractional weights of the liver and thymus, they reduced the weight of the liver about 20 per cent. That is a trigger. If you had a new product that reduced the weight of the liver in the workers in a chemical plant, the president of the company would have had a stroke. If he then called you in and said, "How long have you tested this, McLeod?" and you said, "I tested it two weeks", you would be down in Chicago looking for a job. You do not have any chronic data and your old report here minimizes it because I suspect that some of you have been on the phone to guys like Kessler and those other people down there who we are trying to get let go.

 

Senator Robichaud: I do not think anyone should impute motives on other people.

 

Mr. Von Meyer: I apologize for that.

 

Senator Robichaud: We must be fair.

 

Mr. Von Meyer: Let me make one further statement. We have gone on for an hour with Mr. Pollak about insulin-like growth factor in serum. Insulin-like growth factor does not require circulation in serum to be active on gut lining cells. All it needs to do is nestle up to an epithelial cell and bind to its surface. You know that. If that cell has a mutation in it that pre-disposes it to cancer, you are on your way as regards risk. As the Science report said, from a control of 0 per cent IGF-1 to an increase of 35 per cent, the percentage of time that you have to hit the cell that may have a pre-cancerous mutation in your intestinal wall is increased by 35 per cent.

There is one more point. You have all spoken about ranges of dosages that occur in nature. When you add BST or IGF-1 for milk, it does not fit in a range. It is added to the diet in that amount of additive on that day that you contact it. If you would have drunk normal milk that day with zero IGF-1 in it, you would get the incremental increase. This is an additive effect and it is exactly how we regulated thyroid active materials. They were added to the background nature of anti-thyroid substances.

It bothers me to see that there are these statistically significant oral tests published by your own university but your health people are not talking about them here. Why is it that you are omitting your discussion of this paper? Here is the paper. There is the data. Why are you omitting that discussion?

 

Mr. Pollak: While Mr. McLeod looks at the paper, let me tell you that we are getting down to the all important microlevel.

 

Mr. Von Meyer: That is how you die!

 

Mr. Pollak: We do not want to have a weak Health Protection Branch that does not stand up to big, bad companies. However, we also do not want to have alarmist people coming around and scaring the population where there is no need for fear.

You were talking about our research. Wait until you get your hands on my latest paper, where we show that IGF-1 is related to colorectal cancer. With the data here, I am the objective scientist.

 

Mr. Von Meyer: No.

 

Mr. Pollak: My data is being used by the people who oppose Monsanto. I want to make sure that no one reads into it too deeply or misinterprets it.

Let me get to the point that you raised. You are saying that we should pay careful attention to the IGF levels in the gut. I agree with you that it is very important.

It is important because these little proteins, the IGF-1 in the gut, can tickle the gut lining cells and make them grow. If they are pre-cancerous, they could become cancerous, that is true. Let us be clear here: We are not talking about something that the BST does, we are talking about something that the IGF-1 does. Why are we talking about that? Because the milk that is made by the cow that got the injection probably has a little bit more IGF-1 than normal milk. Therefore, I am all with you so far. I must now bring in some other science, which I am sure will also be interesting.

 

Mr. Von Meyer: May I interrupt for a second?

 

Mr. Pollak: No, because I did not interrupt you.

Here is how it works. One of the best sources of IGF-1 that normal people eat is milk -- that is, non-BST treated milk. The IGF-1 content in regular, natural milk is pretty substantial. It could be in cows' milk, it could be in human milk. Milk normally contains IGF-1. Therefore, we must not be too alarmist and say that BST milk contains IGF-1 that might interact with your gut mucosa and cause cancer. That is something that requires thought. Let us be rigorous here. We must look at the difference of the IGF-1 content in the BST milk compared to the regular milk.

The thing that I should like some help with scientifically is that there are some people who have even less IGF-1 exposure of their guts. Those are people who have no milk at all. People who have no milk at all will have much less dietary IGF-1 intake. I will not quote specific figures but I want you to be aware of this: If you do not drink any milk, you have much less IGF-1 in your diet. If you drink regular milk, we will say that your IGF-1 content becomes 100 per cent. If you drink the BST, then you have, maybe, 110 per cent. I do not want to allow a dangerous product on the market, so I was looking for some data that would be very supportive of the concern that people who do not drink milk have less cancer because they have the lowest IGF of all. However, I could not find it.

 

Senator Spivak: What are the other factors?

 

Mr. Pollak: There are many other factors. I am just talking about the issue of gut exposure.

 

Senator Spivak: That means nothing.

 

Mr. Pollak: The issue of gut exposure to IGF-1 is not caused only by BST. Anyone who drinks milk has it.

 

Mr. Hansen: But they have an increased level. You just said it is 10 per cent; the data which is in the Science article, which some of us would dispute, says 25 to 70 per cent; and in the submission to the European Union, Monsanto said it could be up to five times as high. The first data that was in the published literature said that after seven days it was three times as high. That is 300 per cent, not 10 per cent or these small levels. That is why you need to know the following, namely, how big is the increase? That is what you need to know. The fact of the matter is that there are problems with measurement.

 

Senator Spivak: We have not even talked about antibiotics.

 

Mr. Von Meyer: I listened for an hour and a half without saying a word. You people argued, almost verbatim, like the FDA did in the United States, against chronic testing. This is full of that. That is why I pointed out in my talk this morning the number of cases where we have made mistakes by rapid testing, for example, fialuridene, five people dead; Vacor, 20 people dead.

(TAKE 1320 follows, Mr. Von Meyer continues: We now have an entire technology industry...)

RC/Agriculture 34842/April 26/99

(Mr. von Meyer continuing:)

**We now have an entire technology industry pushing for that entire omission, including you people this morning for an hour. We do not need chronic health data, which is all in this report, while epidemiological divisions in Belgium, Germany and Holland are saying, "Wait a minute. There is something wrong with people who have too much milk." The diabetes problem was linked to milk. Finland also tested thousands of children and found bovine antibodies.

 

Mr. Pollak: Could I ask you a question since you asked me one?

 

Mr. von Meyer: You can interrupt.

 

Mr. Pollak: Do you believe, sir, that there is a difference between BST-treated milk and regular milk in terms of the diabetogenic effects?

 

Mr. von Meyer: I believe there is no data. I will stand for the principle of not testing widely eaten foods when you have the kind of data that I gave you that shows an effect on the liver by oral consumption. I will fight that wherever I can, as long as I can and as long as I can afford it. That is it.

 

Mr. McLeod: May I just read into the record the last sentence from the abstract of this paper?

 

Mr. von Meyer: The abstract does not read with the data. Read the orange data, please.

 

Mr. McLeod: The orange data is the selected quote you were read by Mr. von Meyer. The sentence which follows states:

The effects of milk from bST-treated cows were not different from those of milk from untreated cows following oral ingestion by hypophysectomized rats.

Those are rats which have had their pituitary glands removed.

 

Mr. von Meyer: Excuse me. Did you read the data?

 

Mr. McLeod: I do not want to debate this particular data.

 

Mr. von Meyer: I know. This is what your life depends on, though.

 

Mr. McLeod: This paper is representative of the thousand papers I told you are produced a year on this subject. We looked at a broad cross-section of them, including many of this kind. I do not remember this specific paper. Certainly no one from my panel would disparage the notion that this is of exceptional biological interest -- it is. However, we did try to separate that from what we consider to be the drug regulatory question of whether or not there was evidence that would permit the Canadian government with a clear conscience to keep rBST off the market. That was the question we were asked. That is the recommendation we made.

I thoroughly resent being portrayed as someone who is opposed to more research on this important question. I have spent my whole life doing research. I was the dean of a medical school. We live and die by doing research. We do not normally get into scientific debates where we take selective sentences from papers in front of a panel such as this.

 

Mr. Chopra: I have a brief comment or question for Dr. McLeod. His letter to the Toronto group stated that they had also canvassed many submissions from external people, scientists, perhaps. Who were the people who made submissions to the medical panel?

 

The Deputy Chairman: Before you answer that question from Dr. Chopra, I should like to ask a question. You were interviewed by all sorts of people in Health Canada. Why did you not go to Dr. Chopra and some of the scientists? Were you told not to?

 

Mr. McLeod: Certainly not. I will go back to a comment that Dr. Hansen made. He quoted from a statement from the royal college which said that we were not a committee of the royal college. I suspect that means we are not a standing committee. The royal college is a complex professional organization, as you know, which has many committees. We were an ad hoc committee formed by the royal college, clearly in response to a request from Health Canada. That is undeniable. However, we were most certainly a royal college committee.

As such, we were completely independent to follow whatever process we wished. We did debate at our first meeting whether we should call widely for witnesses and whether we would go through the kind of hearing that you are going through here. Rightly or wrongly, we decided that that was not to be our process. We did put out a request for submissions. Certainly at that time during the summer I was receiving frequent phone calls from people who had concerns, people such as the Metro Toronto Food Council. My response to all of them was, "Please feel free to submit anything you wish to this committee."

 

Mr. von Meyer: When was the committee review meeting held?

 

Mr. McLeod: The committee met over several months beginning in July of last year.

 

Senator Spivak: I am not really clear as to what you consider is the proper scientific process for review of biotechnology products. Do you think there is a variety of procedures? We are not talking about politics, which I understand.

The reason I ask this question is because I understand that what is being suggested is risk management. That is what is troubling me. I do not know if that is appropriate.

What is your opinion as to the appropriate scientific procedure, without getting into what I know will be a horrendous question?

 

Mr. McLeod: I think you are right. The big issue here is not, as you said a few minutes ago, risk management, but risk analysis or risk assessment. You cannot manage the risk until you know what it is. One of the problems we have is that we do know with certainty what the risk is. However, that is true of many other things as well as insulin growth factor.

Therefore, if there is something to be done legislatively in Canada, it really should address this issue of risk assessment and risk management. Perhaps that is a new or expanded role for the Health Protection Branch. It is there implicitly in the documents that describe the Health Protection Branch. However, as I am sure you realize, the Health Protection Branch simply does not have the human or fiscal resources that would be required to meet that whole mandate.

If you start to get into questions of risk analysis, whether it is about drugs, earthquakes, volcanoes, or whatever, you need a scientific complement who can address those things.

The challenge is that we do not presently have the kind of scientific complement required. It is not just in the Canadian government; I do not think we have the scientific complement in Canadian universities to deal with this. There are very few institutions that have focused on risk analysis and risk management as part of their mandate. There is a tremendous shortage of qualified personnel who can do this. I say that coming from McMaster which has probably more resources than most institutions.

 

The Deputy Chairman: Thank you all for coming today. I do not know if I am any better informed now than I was before. I still have strong reservations about this product. I am appalled and shocked that we have had so much debate on an unnecessary product that we do not need in our society.

We will continue to work to ensure any way we can to do that kind of testing and research which can alleviate some of the doubts.

As I think Mr. Pollak or one of the witnesses said, in our society today there is so much concern that everything is big and it is being thrust upon the people without any concern for them.

The chairman of the committee and myself have received over 1,400 letters from people across Canada. They have told us that they never had any use for the Senate before, but they point out that the work the committee has been doing is outstanding. We have not received one condemnation for what the committee has been doing. I think you called us heroes. We do not look at ourselves as being heroes.

(take 1330 follows The Deputy Chairman continuing: We see ourselves as parliamentarians...)

(The Deputy Chairman continuing):

**We see ourselves as parliamentarians trying to do a job for the society we represent.

 

Mr. Pollak: I should like to mention one of the bigger themes here, if I may carry on with Dr. Chopra's history of regulation. He described how the regulatory authorities had to leapfrog as technology grew from the turpentine days. We are here now in part because the biotech industry has taken another leap forward. It would be desirable for this committee to reinforce the point that the regulatory authorities have to become more sophisticated to regulate this new kind of activity. We should not expect a set-up that was supposed to approve or disapprove drugs such as penicillin to deal with this new kind of product. We have to retool our authorities to deal with the new regulatory challenges.

 

The Deputy Chairman: Two years ago in February, I was a perfect example of the use of good biotechnology. My life was saved in the London University Hospital when I had a dissected aorta. I am running around now with a piece of plastic pipe in me. I told the Prime Minister that God only let me live so that I could come back and be his conscience and also be the conscience of companies like Monsanto.

The committee adjourned.

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