CHERYL MILLER'S SPEECH TO
JOHNE'S DISEASE COMMITTEE OF USAHA
October 23, 2000

Full text of speech

My name is Cheryl Miller. I am not a scientist. I am a mother. Along with Karen Meyer, I am Co-Executive Director, Paratuberculosis Awareness and Research Association, Inc., a Crohn's patient advocacy organization concerned that the devastating and debilitating human disease known as Crohn's disease is caused by the bacterium in cattle known as Mycobacterium avium, subspecies parartuberculosis (MAP) which causes Johne's disease in cattle.

I want to take a moment to recognize several individuals who are here today. First, Steve Merkel -- Steve is a member of PARA's Board of Director's as well as our webmaster and an integral part of our effort. Additionally, we are pleased to announce that individuals from the U.S. Centers for Disease Control have also joined the meeting today.

I want to concentrate my comments today on specific areas of concern as follows:

I. What is Crohn's disease?

II. Could MAP be a Human Pathogen?

III. Is live MAP in our food?

IV. Critical Elements in an adequate Johne's Disease Control Program

V. Summary

I. What is Crohn's Disease?

Crohn's is a devastating and often debilitating disease. Lifelong, chronic and progressive in nature, Crohn's most commonly strikes the young, with more and more young children being stricken every day.

Crohn's is a very painful inflammatory disease causing ulcers. And, most often (as with Johne's disease in cattle), Crohn's disease targets the distal small bowel or what is known as the ileum and results in malnutrition/wasting. Also, as with Johne's disease in cattle, Crohn's is a systemic disease.

Conventional treatment in Crohn's treats only the symptoms. Serious Complications frequently occur in Crohn's disease.

The effects are frequently heartbreaking to patients, as well as families and loved ones who experience fear, frustration, anger, helplessness, etc.

The outcomes of Crohn's are often devastating - lives filled daily with misery and pain, multiple major surgeries, and declining quality of health.

II. Could MAP be a human pathogen?

Occasionally, PARA still hears the statement that "MAP is not conclusively proven to cause Crohn's."

In May of this year, we discussed this statement with key individuals at the National Institutes of Health. We were told that the only test that would "conclusively prove" that MAP causes Crohn's would be to infect human children with the bacterium and cure them - and that such a thing would never be done of course.

It was further explained to us that, as with so many other diseases, the proof of the cause of Crohn's will most likely be "found" as the result of a change in "Paradigm" about what causes Crohn's. More specifically, historically what happened with numerous other diseases was that, as the scientific evidence continued to mount and as more and more people came to believe it, then the "cause" became "known and accepted" -- in essence, based upon mounting scientific evidence, a "shift in paradigm" occurred.

Consequently, we wanted to take a few moments to review with you the currently existing scientific evidence about MAP and Crohn's.

a. Summary of Evidence Published in Peer Reviewed Scientific Journals (some dating as far back as 1981):

• Numerous diseases in cattle can be passed to human beings through cattle/cattle products (e.g. tuberculosis)
• MAP is a pathogenic bacterium, which causes chronic intestinal disease in a wide range of animals, including sub-human primates and cattle
• MAP causes Johne's disease in cattle. MAP (Johne's disease) infection in cattle bears remarkable clinical similarity to Crohn's disease in humans (e.g. chronic or intermittent diarrhea, ileum/intestinal/systemic involvement, wasting, etc.)
• MAP infection (Johne's disease) prevalence is increasing in cattle. Similarly, the prevalence of Crohn's disease is reported to be increasing in human beings
• MAP is excreted in the milk of dairy cattle infected with Johne's disease (MAP infection)
• MAP in milk may survive pasteurization. Indeed, in the majority of studies scientists have concluded that MAP appears capable of surviving current U.S. pasteurization standards
• MAP has been found in resected intestinal tissues of Crohn's disease patients by bacteriologic culture
• Mycobacterium parartuberculosis has been found by bacteriologic culture in the breast milk of lactating Crohn's patients
• MAP has been found in significantly higher numbers of Crohn's disease/IBD patients versus control patients by genetic probes
• MAP found in Crohn's disease patients is of the Bovine (cattle) strain
• Crohn's disease appears to present in two distinct forms (perforating and nonperforating). The same is true of at least two other diseases caused by mycobacterium -- specifically tuberculosis and leprosy
• It has long been recognized that certain antibiotics sometimes "...seem to improve the course of Crohn's disease
• Profound remissions in Crohn's disease patients have been induced using anti-mycobacterial drug therapy which kills mycobacteria. These anti-mycobacterial drugs are classified as "macrolide antibiotics" and include antibiotics such as Clarithromycin. (Note: One study alone documented profound remission in excess of 80% of Crohn's disease patients using combinations of certain antibiotics, including "macrolide antibiotics," which kill MAP)

Now, add to the above published studies the fact that more recent scientific studies using newer methodologies provide corroborating antibody evidence that CD patients are infected with MAP.

Collectively, the above scientific information/evidence suggests that, at least some cases of Crohn's disease/IBD may be caused by infection with MAP and that MAP infection may possibly be contracted through human ingestion of unpasteurized and pasteurized milk and/or cattle products. Moreover, these studies further suggest that the possible cure (or at least long-term remission) for Crohn's disease may be treatment with certain combinations of antibiotics which kill mycobacteria.

b. Additional Considerations. Beyond all of the above, the bulk of which is determined by scientists in repeated published studies, we ask you to consider the following:

• many mycobacteria have been proven to be both animal and human pathogens - as example M. tuberculosis, M. Leprae, M. Avium, etc.
• MAP is a distant cousin of M. Tuberculosis and MAP is a subspecies of M. Avium which are both known human pathogens
• MAP has been proven to infect sub-human primates
• The pathology of Johne's disease (MAP infection) in cattle is similar to the pathology of Crohn's disease in humans with the usual target site the ileum/intestine and systemic involvement
• The clinical signs of Johne's disease (MAP infection) in cattle is similar to the pathology of Crohn's disease in humans with chronic or intermittent diarrhea and wasting
• Crohn's disease in humans and Johne's disease in cattle both appear to be the result of infection early in life which manifests later
• It is generally know that infectious organisms commonly cross the species barrier to infect other species

Now, in response to those who would continue to state that "it is not conclusively proven that MAP causes Crohn's disease," we ask you, "What other mycobacterium can you name that is capable of doing all of the above and is NOT a human pathogen?"

III. What are the chances that live MAP is in our food?

As a bit of history, in 1993 - seven long years ago -- the first scientific study was published indicating that MAP may survive pasteurization standards used in the U.S.

This study was ignored by federal agencies responsible for food safety in this nation. Much later, in 1998, when University of Wisconsin researchers published their findings that MAP was able to survive current US pasteurization standards, it was again ignored by our U.S. Federal Agencies cognizant of food safety. All in all, during the period 1993 through 1998 - five long years -- six studies came in from the US and around the world which suggested that MAP may survive current US pasteurization standards/practices and all of them the were tossed to the side, ignored by cognizant US Federal Agencies such as USDA/FDA.

While our U.S. Federal Agencies ignored these significant findings smaller and less able nations stepped to the forefront in this issue. Indeed, the UK, a relatively small nation with only about one-fifth the population of the U.S. and less than 15% off the Gross Domestic Product of the US took action and in August 1998, the United Kingdom's (UK's) Ministry of Agriculture and Fisheries (MAFF) undertook a nationwide study to investigate the microbiological quality of raw and pasteurized cows' milk in the UK.

During this same timeframe, Ireland also stepped to the plate taking dramatic steps to remove MAP from the food chain. A summary of the 11 August 1998 Press Release From Food Safety Authority of Ireland set forth the following:

1. Irish regulators require that animals diagnosed with Johne's disease are removed from the food chain
2. From the time an animal is diagnosed with JD until it is culled, milk will not be used (pasteurized or raw) for humans or calves
3. On no farm where there have been cattle diagnosed with JD (and there might be subclinically affected animals that are not yet "diagnosable" by currently available methods) the milk will not be used without pasteurizing it.

What is the situation today?

Findings from the U.K. study have been published stating that live MAP was found in retail milk in the U.K. It should be noted that U.K. pasteurization standards are equal to or exceed those used in the U.S.

Studies which have found that MAP may be capable of surviving pasteurization:

1. 1993: Chiodini, R. J. and J. Hermon-Taylor. 1993. The thermal resistance of Mycobacterium paratuberculosis in raw milk under conditions simulating pasteurization. J.Vet. Diagn. Invest. 5:629-631.
2. 1996: I.R. Grant, et al. 1996. Inactivation of Mycobacterium paratuberculosis in cows' milk at pasteurization temperatures. Appl. Environ. Microbiol. 62:631-636.
3. 1996: Meylan, M. etal. 1996. Survival of Mycobacterium paratuberculosis and preservation of immunoglobulin G in bovine colostrum under experimental conditions simulating pasteurization. American Journal of Veterinary Research 1996;57(11):1580-1585.
4. 1996: D. Millar, et al. 1996. IS900 PCR to detect Mycobacterium paratuberculosis in retail supplies of whole pasteurized cows' milk in England and Wales. Applied and Environmental Microbiology 3446-52. September, 1996.
5. 1996: Hope AF, Tulk PA, and RJ Condron. Pasteurization of Mycobacterium paratuberculosis in whole milk. Proceedings of the Fifth International Colloquium on Paratuberculosis, p377-382
6. 1998: Sung N. and Collins MT. Thermal tolerance of Mycobacterium paratuberculosis. Applied and Environmental Microbiology 64(3), 999-1005
7. 2000: I. Grant. Findings in the U.K. of live MAP in retail Milk
8. 2000: German study (not yet published, but presented by J. Stabel in NJWG, October meeting 2000) finding that MAP may survive pasteurization

Studies which have found that MAP does not survive pasteurization:

There are two published studies - a USDA study and one from the University of Georgia which suggest that MAP may not survive pasteurization. Both of these studies have had significant criticisms levied at them from the scientific community. Methodology of the USDA study has been criticized and the Georgia study has been criticized for a misinterpretation of data generated in the study.

So, considering the available scientific evidence, it appears that there is a very high likelihood of live MAP in retail milk in the U.S. Nevertheless, some argue that the data remains incomplete.

The Center's for Disease Control issued the following statement relative to incomplete data: "Consumer health takes precedence over market concerns, and when data are incomplete, a conservative response is warranted until the risk can be accurately assessed."

Smaller and less able nations have acted and/or are in the process of determining action to ensure the protection of the public health relative to live MAP in food supplies.

Sadly, to date, federal agencies in the U.S. responsible for food safety have not taken the "conservative approach" and have not acted to exercise the precautionary principle in the U.S. to ensure the protection of the public health relative to the potential threat posed by MAP. In the opinion of PARA, the failure of these federal agencies to take swift action to ensure the protection of U.S. citizens is nothing short of a national disgrace.

IV. Critical Elements of an Adequate JD Control Program

PARA is pleased that a proposed Johne's Disease (JD) Control Program has been set forth to remove, at the farm gate, JD infected dairy cattle/milk from the food chain. PARA would like to stand with industry in support of an adequate plan to remove MAP from the food chain. However, PARA cannot support the plan as proposed.

This is because our review of the proposed JD Control Program disclosed that, while there were many strong elements, the proposed Program does not contain all necessary precautions/controls to ensure the protection of the public health.

In this connection, PARA very strongly encourages significant strengthening of the Proposed JD Control Program to include the elements described below:

1. Program must be mandatory, not voluntary, and must be implemented consistently throughout the U.S.
2. From the time an animal is diagnosed with JD until it is culled, milk will not be used (pasteurized or raw) for humans or calves. Milk from these cattle will be disposed of in accordance with policies governing biohazardous waste.
3. On farms where there have been cattle diagnosed with JD (and there might be subclinically infected animals that are not yet "diagnosable" by currently available methods) the milk will not be used for human or calf consumption, even after pasteurization. This milk will be disposed of in accordance with policies governing biohazardous waste.
4. Pooled milk from cows of unknown Johne's disease status will not be used to feed humans or calves, even after pasteurization. This milk will be disposed of in accordance with policies governing biohazardous waste.
5. Culled JD-infected cattle will not be sent to slaughter houses due to cross-contamination concerns. Beef, beef by-products, and offal from these cattle will be strictly prohibited from entering the food chain in any form, and will be disposed of in accordance with policies governing biohazardous waste.

V. Summary

• What is Crohn's? Crohn's is a horrific, debilitating disease of the young.
  
  
• What are the chances that Mycobacterium avium, subspecies paratuberculosis (MAP) is a cause of Crohn's Disease? Based upon the available scientific evidence - the ability of the MAP to infect sub-human primates, the fact that other mycobacteria -- some "cousins" of MAP -- are known human pathogens, the fact that MAP infection (Johne's disease) in cattle has similar clinical and pathological manifestations, and the general nature of infectious organisms to "cross the species barrier" -- it appears that Mycobacterium avium, subspecies paratuberculosis (MAP) is a very plausible cause of Crohn's Disease
  
  
• What are the chances that live MAP is in our food? Eight out of 10 studies suggest that MAP may survive U.S. pasteurization standards. The two studies which disagree with these findings have been staunchly criticized by the scientific community -- one study for inadequate methodologies and the second for a misinterpretation of data.
  
  
• Critical Elements Necessary in an adequate Johne's Disease Control Program. An adequate Program/Plan would prevent MAP entering the human food chain. PARA would be pleased to support an adequate JD Control Program.