Full text of Karen Meyer's Speech at USAHA'S 1999 Meeting of the Johne's Disease Committee - San Diego, California

It's hard to believe that it was two years ago that I first addressed this committee. A lot has happened in these past two years. PARA began with a few Crohn's patients and their loved ones who were concerned about the link between Crohn's and paratuberculosis, and has grown to an organization with members from all over the world. Our websites have had over 50,000 visitors in the past two years, and we expect the level of awareness to continue to grow as we have just published a new web site, with an ideal domain name of www.crohns.org.

Much has changed in the world since that 1997 meeting, as I think you will all agree. Other nations, Australia and the Netherlands, have embarked upon aggressive programs to control Johne's in their countries. Recognizing that paratuberculosis contaminated milk poses a public health threat, the United Kingdom's Ministries of Agriculture, Fisheries and Food are testing retail milk to determine the scale of the problem. The lessons learned by the UK Government BSE crisis have not been forgotten. They realize that mounting PR campaigns to assure the public that there is no food safety problem---while crossing your fingers behind your back---is simply not enough. Since many of the world's nations are finally dealing with the problem, that leaves us behind in the race at this point in time.

We were encouraged by Friday's NJWG (National Johne's Working Group) meeting in many ways as well as the meeting today. There appears to be a growing movement to tackle this problem, and many producers are looking out for their own interests. Those who are forward thinkers have realized that the NJWG isn't going to get them out of this mess---the Johne's Disease Committee isn't going to get them out of this mess---and the Government isn't going to get them out of it, either. It's not the Government's responsibility, and the sooner you realize that, the better off you will be. You producers are at a place where the rubber meets the road, so to speak. Like us, you are the ones who have so much to lose.

Now, please understand that I only have an elementary understanding of how your organizations work. From what I can gather, the National Cattlemen's Beef Association is well organized. But it appears that the dairy industry is very fragmented, and does not have the infrastructure in place to represent the interests of the producers adequately. If there are organizations you have been relying on for your information and to protect your interests, they have failed you miserably. Perhaps now's the time to form a producer-based organization that will protect you, the producer. Where would you dairy producers be if overnight there came a directive from the processors that they would only accept milk from test-negative herds or test-negative cows?

I would challenge the dairy industry to step to the plate like the beef industry has. Assume your responsibilities and become proactive as well. It will be an investment of resources that will benefit your industry, whether or not a link with Crohn's disease is ever proven.

On Friday, once again I voiced PARA's concerns over the NJWG's not adequately fulfilling its objectives, and totally ignoring the first objective to "evaluate information suggesting M. paratuberculosis is a zoonotic pathogen and assess the likelihood that animals serve as a reservoir of infection." That certainly has not changed. Still nothing has been done to fulfill that objective.

Our criticisms of the NJWG's failure to meet the other objectives are based on the fact that in the four years that the Working Group has been in existence, in terms of real action being taken, nothing has been done to halt or even slow down the spread of an infectious agent that may be causing enormous human suffering. In that amount of time, 100,000 new cases of Crohn's disease have been diagnosed, and most of them have been young people, between the ages of 15 and 25.

But today, in all fairness to the committee members who have put in so much time and energy into various areas, we want to acknowledge that the NJWG did produce some meaningful reports and information, most notably the herd certification program produced by the Herd Certification Subcommittee co-chaired by Leslie Bulaga and Mike Collins. The practicality of this plan and the reasonable cost of implementation leave industry with no excuse for not cleaning up the herds.

Also in the area of education, we would like to thank the National Cattlemen's Beef Association (Gary Weber, if you are here, thank you), for being proactive on this issue. They heeded our warning of two years ago and have taken action in the form of producing the Guide to Johne's Disease in an attempt to educate their producers. We are extremely pleased that they are sharing it with the dairy producers as well. You are all going to need to work together to solve this problem.

We are also encouraged by the fact that some states are embarking upon control programs and are taking measures to begin to control Johne's in their herds.

We are pleased that you have voted unanimously to endorse the National Research Council's Proposed Study on Diagnosis and Control of Johne's Disease. We, too, are supportive of that study, and we urge the beef and dairy industries to contribute to funding for this project.

I'd like to now share with you some significant things that have happened in the Crohn's disease area, the human health side of this issue. In the past year we have seen NIH address the problem---and as you will hear in a moment, the CDC is addressing the problem---the National Research Council is expressing an interest in the issue, and last but certainly not least Congress is taking notice. Last year we were able to gain the support of Congressman Dennis Kucinich from the State of Ohio. Congressman Kucinich is keenly interested in this issue because he serves on the Government Reform Committee and on the subcommittee that ultimately has oversight over FDA and therefore over milk safety. I'd like to quote from a recent letter from Congressman Kucinich to Chairman Rotenberger:

"There has been sufficient scientific evidence to justify concern about the possibility that the bacterium, Mycobacterium paratuberculosis, in cows might cause Crohn's disease in humans, and that it survives the milk pasteurization process. It is estimated that between 500,000 and one million people in the United States suffer from Crohn's disease. Approximately 55 Americans, mostly between the ages of 15 and 25, will be diagnosed with this disease every day. More research on Johne's Disease is important and will benefit livestock, farmers, and consumers of meat and dairy products, as well as scientists and doctors investigating the human condition of Crohn's disease. I believe that there needs to be more funding for research to guarantee the safety of milk and meat products from cattle. I know you will make efforts to bring attention to this issue, and I, too, will raise awareness among my colleagues in Congress about the importance of conducting more research on these two diseases."

So, unlike when we addressed this committee two years ago, there are many watchful eyes focused on these proceedings. You can no longer expect to handle this problem in-house.

While we may not see eye to eye on this issue in many ways, there are things that we can all agree upon. One is that adequate and exhaustive research is the only thing that is going to end this controversy. As you know, paratuberculosis research has always been plagued by researchers having to work on shoestring budgets. Yet, in spite of that, thankfully there is a small group of dedicated researchers who persist. Researcher Dr. Saleh Naser, microbiologist with University of Central Florida, and Orlando Gastroenterologist, Ira Shafran, have reported that MAP was cultured from the breast milk of two lactating Crohn's disease patients. I'll read you the concluding remarks from the abstract, which has been submitted for publication:

"Identification of M. para in cultured milk samples from CD patients clearly demonstrates the gross similarity between humans diagnosed with CD and mammals infected with M. para. This report is first to describe the presence of M. para in milk samples from CD patients, thus adding more support to the mycobacterial role in CD pathogenesis. A need for a larger-scale investigation to detect M. para in human's milk is strongly indicated. M. para strains reported here will be submitted to the American Type Culture Collection."

We are extremely pleased that a clinical trial is underway in Australia. It is a very large trial and should provide valuable data, which will benefit Crohn's patients.

Another important development, one that has the potential for far-reaching implications is news coming out of the Centers for Disease Control. PARA has been authorized to share the following statement:

"CDC is taking this matter very seriously. CDC is now making moves that are supportive of the need to identify risk factors for human infection..."

Since meetings are ongoing, it would be premature to share details, but I have been assured that a formal response will be forthcoming in the near future. The fact that CDC is now moving to action is quite significant, as you all know.

Now on to the Research Agenda published by the National Institute of Allergy and Infectious Diseases in May of this year. This report describes the research necessary to understand, diagnose and treat infectious causes of Crohn's disease. Because the report is so extensive, I will only focus today on the fifth conclusion drawn by this expert panel:

"If MAP is proven to be a human pathogen, there is the potential for an enormous impact on human health due to the prevalence of this organism on the farm and in water. Further study of MAP as a food and/or waterborne pathogen should be conducted. Viable MAP should be sought in commercial milk and other dairy products as well as in meat."

This last point validates the position PARA has maintained for two years and which is our third stated objective: TEST THE RETAIL DAIRY AND BEEF PRODUCTS ON OUR SUPERMARKET SHELVES! Now that the NIH has recommended it, how can a position to do otherwise be defended?

In addition to the conclusions that make up the initial part of the NIAID Report, there are 15 areas covered in the basic and clinical research sections. The language in these is quite technical, so I'm not going to read them to you, but I do encourage you to read these recommendations in their entirety. They are available on our web site.

I am no scientist, but it is clear from reading these recommendations that the NIAID is very serious about research...and that they intend to use cutting edge technology to do it.

Indeed this Research Agenda is exciting...but one obstacle stands in the way of its implementation: Funding. It is PARA's intention to approach the U.S. Congress in order to obtain this funding. We are extremely optimistic that we will be successful in our efforts, but our success will be ensured if we have the support from major political and industry groups. Certainly, we will now use USAHA's 1997 Resolution No. 13:

".... Members of USAHA are urged to seek greater congressional awareness and support to adequately fund Johne's and Crohn's disease research needs."

Thankfully, that recommendation survived the final USAHA vote in 1997, unlike last years Johne's Disease Committee recommendation for beef testing.

The research proposed by NIAID certainly will benefit the animal industry significantly, with much of it specifically directed at animal research, which will no doubt lead to improved diagnostics, something all of us want.

I live in the State of Florida, and while Florida is a great place to live, one of the negative things about living there is the threat of hurricanes. In many ways the Crohn's/paratuberculosis situation can be likened to a hurricane threatening to make landfall. The storm has been brewing for quite a while, but no one paid it much attention---that is, until it got close to the mainland.

As everyone in this room knows, the ParaTB storm is looming in the distance. When it will make landfall is mere speculation. But when it does hit, will you be ready for it? There are no evacuation routes in this storm...so you'll have to weather it. This is not an isolated thunderstorm we're dealing with...it's a Category 5 Hurricane that is rapidly approaching land. Given the unpredictable nature of hurricanes, what you are experiencing today may be the calm before the storm that hits tomorrow.

When the winds of public debate hit, will you be ready? When millions of Crohn's patients ask questions, will you have answers that will satisfy them as to whether their disease was preventable? When accountability issues arise, will you be able to confidently rely on your actions to protect you from legal liability and/or ethics violations? I suspect that if that storm hits, not only will there be great economic losses, but the cozy relationships that now exist between industry and government will be affected when the American public begins asking questions. THEN...the regulators will finally do their job of regulating. I am sure that if you had asked the tobacco executives if they would have ever dreamed the U.S. Government would sue them, they would have replied with a resounding, "Never." One thing I have learned in my years on this earth is: Never say "never".

In closing, I'd like to share several reasons why PARA was formed...these reasons come in the form of human suffering.... these are real messages shared by two mothers writing into a support group forum on the internet. The first is the one that prompted me to make my first phone call to the FDA back in May of 1997. It had an emotional impact on me that was profound...probably because the young man was one year older than my son who was then 22. It was at the moment that I read this message that I knew I could not stand idly by.

(Message read.)

The following message was printed this past weekend. Unfortunately, there is never a shortage of these messages. This is from the mother of a 5-year-old girl:

(Message read.)

One thing that struck me in these two messages is the brave front these mothers are putting up. They are trying to keep their emotions in control so that they can ask coherent questions in this forum. What is not apparent in these messages is the horror they experience as they watch their children suffer...what is not apparent are the sleepless nights where they cry out to God to spare their child and take them instead....what is not apparent is the utter emptiness they feel as they go through life with the knowledge that their child will never live up to his or her full potential because of this disease. You see, we who live this disease know these things...you wouldn't....you've never walked in our shoes. I pray that none of you will.

What a tragedy it will be if the evidence should prove that our children are being infected with MAP and that it causes the devastating disease known as Crohn's Disease...and although it was within our power to protect our children, we chose not to do so.