October 14, 2002
FORMAL STATEMENT TO THE JOHNE’S DISEASE COMMITTEE, NATIONAL JOHNE’S WORKING GROUP AND UNITED STATES ANIMAL HEALTH ASSOCIATION
For the first time since 1997, PARA has made a decision not to attend this year’s USAHA meetings. Contributing to our decision is first and foremost the ineffectiveness of the NJWG and JD Committee’s failure to deal with the zoonotic potential of Crohn’s disease, the reason the NJWG was formed, a fact that PARA has had to remind them of for five long years. It is interesting to note that the website page for the NJWG Mission Statement (http://www.usaha.org/njwg/njwgmiss.html) is “under construction” and has been since 7/3/99. On the other hand, PARA’s website at http://www.crohns.org/government/usaha/njwg.htm has complete details about the NJWG Mission statement and its failure to address the first two objectives of the original mission statement which are: “(1) NJWG will evaluate information suggesting M. paratuberculosis is a zoonotic pathogen and assess the likelihood that animals serve as a reservoir of infection; (2) NJWG will evaluate the potential for the organism to contaminate foods of animal origin.”
While Crohn’s patients have continued to suffer, it has been extremely frustrating for us to witness the feeble, half-hearted and ineffectual attempts of controlling Johne’s disease being made by the animal industry and regulatory agencies responsible for their monitoring. As a result, we have come to the conclusion that our time and resources can and should be spent elsewhere.
In the five years since PARA’s inception, many strides have been made in creating awareness about the MAP/Crohn’s connection, and we have been told by many that our group is responsible for having contributed to that increased awareness on a worldwide basis. Our website is the main vehicle for conveying our position and concerns (www.crohns.org). We would encourage you to visit the website, particularly in the coming weeks, when it will be completely updated. Some of the items that will be highlighted on the site are listed below. Usually we address updates to the committee in our speeches, but since we will not physically be present, we would like to share these updates with you in this letter:
NATIONAL INSTITUTES OF HEALTH – Based upon its May 1999 Research Agenda, and subsequent scientific proposals, NIH has now funded significant scientific research into the Crohn’s/MAP concerns. This significant funding has happened as a direct result of PARA’s liaison efforts with the NIH. Last year USAHA adopted Resolution No. 21 entitled “Committee on Johne’s Disease Subject Matter: Zoonotic Potential of M. Paratuberculosis.” That resolution came at least five years too late. Why wasn’t it adopted in the 1997 meeting when PARA first urged the USAHA to take action on this grave issue, or why wasn’t it adopted in 1995 when the NJWG was formed to address the zoonotic potential of M. paratuberculosis? Instead, in 1997 an absolutely meaningless resolution was adopted by USAHA about creating more congressional awareness about the MAP/Crohn’s connection.
It should be noted that 1997 resolution was never followed up with any type of action in terms of submitting it to Congress and/or lobbying Congress in this area; it was merely lipservice. On the other hand, PARA has lobbied Congress since 1999 and, in fact, we were successful in getting language adopted into House and Senate Appropriations Bills in 2000, urging NIH and CDC to allocate funding for research. Without a doubt, that is finally happening, because of PARA’s efforts, not USAHA’s.
CENTERS FOR DISEASE CONTROL - As a result of PARA’s liaison efforts with the CDC since 1998, they are taking significant action. In furtherance of their “Working Document on Potential Infectious Etiologies of Crohn’s Disease,” research has been moving forward at a significant pace. Funding is in place for an extensive epidemiology study, to be completed in the summer of 2003. Obtaining meaningful information regarding incidence/prevalence of CD will be extremely helpful since CD is rising at such an alarming pace. Also, research is “moving forward” in the area of improved diagnostics. We anticipate the level of concern to increase in the coming months and years as more and more strides are made in these areas.
MARSHFIELD CLINIC RETAIL MILK STUDY – Since the summer of 1997, PARA has been urging the FDA to conduct retail milk testing here in the U.S., and the FDA has consistently ignored our concerns. Additionally, for five years we have been urging USAHA to adopt resolutions to test the milk and beef products which are being consumed by our nation’s children. But, this was to no avail. In effect, USAHA has also consistently ignored our concerns because no resolutions have ever been adopted. The political manipulation that has taken place with regard to this critical issue is a matter of record and will one day be a matter of public concern, no doubt. It became apparent to us several years ago that those resolutions were important for one reason: To protect the record, a record that clearly indicates that USAHA has failed to protect consumers.
We are extremely pleased to report that FINALLY a retail supermarket milk study is now underway at the Marshfield Clinic in Marshfield, Wisconsin. Results of that study will be published in the summer of 2003. Recently, FDA was contacted by PARA for a comment on the Marshfield Study and clarification of their position about the safety of retail milk supplies in the US, in light of recent UK findings to the contrary. Not surprisingly, no one at FDA’s CFSAN would speak with us, instead referred us to the Risk Assessment Department, to their attorneys. Sadly, it appears that FDA considers PARA, the organization, more of a risk than PARA, the bacterium. FDA’s position remains the same: They will not exert the precautionary principle.
EUROPEAN COMMISSION – The milk study published in May of this year and submitted in November of 2001 by Dr. Irene R. Grant and her team in the UK (“Incidence of Mycobacterium paratuberculosis in Bulk Raw and Commercially Pasteurized Cows’ Milk from Approved Dairy Processing Establishments in the UK”) confirmed that MAP survives pasteurization standards used in the UK – the very same pasteurization standards used in the United States. This prompted the Advisory Committee on the Microbiological Safety of Food (ACMSF), which advises the UK Government Food Standards Agency, in December of 2001 to approve a comprehensive program of measures aimed at eliminating MAP from retail milk, as purchased by consumers. As the ACMSF says in its strategy document: ".... the Agency has put to one side the question of whether or not there is a link between MAP and Crohn's Disease. The Agency believes that precautionary action to reduce human exposure to MAP should start now and should not be dependent on waiting for the link to be proven."
PARA greatly welcomes these developments, and commends the UK Government on its willingness to act in the best interests of its citizens and the best interests of the public health. Unfortunately, US food safety regulators and animal industry leaders have taken the opposite position of perpetuating human exposure till a link is proven, literally gambling with the lives of millions of suffering people.
AUSTRALIAN ANTIBIOTIC CLINICAL TRIAL UNDERWAY– A phase III clinical trial of anti-paratuberculosis antibiotic therapy for Crohn's disease is ongoing in Australia. The antibiotic regimen under trial is a combination of Rifabutin (Mycobutin, Pharmacia & Upjohn), Clarithromycin (Biaxin/Klacid/Klaricid, Abbott Laboratories) and Clofazimine (Lamprene, Novartis). The Australian phase III trial involves over 200 patients with Crohn's disease, in all major cities across Australia. The purpose of the trial is to determine if anti-paratuberculosis antibiotic therapy is a more effective treatment for Crohn's disease than standard immunosuppressant therapy. This trial is a continuation of previous phase II trials which showed promising results using this and similar treatment regimes.
PARA has had to battle politics in the medical arena as well as animal agriculture and food safety arenas because of the medical community’s reluctance to accept change and think outside the box of existing theories. However, in critical circles at the highest levels such as NIH, the paradigm is shifting in terms of Crohn’s disease being addressed as an infectious disease rather than strictly an autoimmune disease. Indeed, the scientific evidence is mounting, and the medical and scientific communities (both human and animal) will be forced to take note of important studies being published that support the concerns about MAP as a cause of Crohn’s disease. We would encourage you to visit a newly created section of our website that will list and summarize these important studies. This section should be published on the website sometime in November.
Rather than spend more of our precious resources trying to get you to take the critical steps to ensure the protection of human health that you should have taken years ago, we will close this letter with verbiage taken from letters sent to USAHA’s Presidents and Officers in 1999 and 2000. (It should be noted that USAHA’s Presidents and Officers have chosen not to respond to any of our communications. Those letters can be read in their entirety on the PARA website “Paper Trail,” a compilation of nearly 70 letters that PARA has sent to and replies from various agencies of the US Government and industry.)
Quoting from our letter to Dr. Hillman on December 1, 2000: “Consider, if it is proven that MAP is causing Crohn's disease, how badly would the dairy industry be damaged if mothers were to find out that the milk they give their babies contains bacteria that have been implicated in a devastating disease? Similarly, if it is proven that MAP is causing Crohn's disease, how badly would the beef industry be hurt if it were proven that Happy Meal hamburgers contain a human pathogen?
“Finally consider, if it is proven that MAP is causing Crohn's disease, how angry consumers would likely become if they come to believe that the beef and dairy industries had good scientific reason to be concerned about the potential safety of their products, and yet they had failed to take any precautionary measures, and further, that they had failed to support research to determine whether viable MAP enter the human food chain through dairy and beef products.
“We would like to point out that during the congressional hearings in recent years concerning the Firestone tire issue, the pivotal question was not: ‘Why are the tires bad?’ Rather, the question was: ‘WHEN did you know there was a risk to consumers?’
“The dairy and beef industries can never claim that they were not sufficiently warned about the potential impending crisis. The consequences for these industries could be catastrophic if it is proven that the industries had good reason to suspect a potential problem with their products, and yet, although it was within their power to exercise the precautionary principle to protect the children of this nation, the industries, nevertheless, chose not to do so.
“We at PARA are saddened that USAHA has once again chosen to be part of the problem rather than part of the solution. Your actions have undoubtedly contributed to the PUBLIC BETRAYAL that has taken place surrounding the debate on the MAP/Crohn's disease issue.”
The words of that letter ring true today, given pathetically little has been done on this problem in terms of actions that will have much meaning in terms of controlling MAP. Until such time that regulators at the USDA implement a mandatory control program, which includes prevention of MAP-infected food products from entering the food chain, our children in this nation remain at risk. One day consumers will want to know why and who is responsible!
In closing, the summer of 2003 will be an important time in the area of MAP/Crohn’s research, with the forthcoming research from NIH funded grants, with the publication of the CDC’s epidemiology study, and publication of results of the Marshfield Retail Milk Study. Certainly, we of PARA are anxiously awaiting all of these studies. Will these areas of research validate our long held concerns? We believe so. It is our prediction that very soon industry and regulators will be forced to deal with the issue, despite their obvious reluctance to do so.
BOARD OF DIRECTORS
Paratuberculosis Awareness & Research Association