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PARA REPORT

LocationReport Date

Washington, D.C.

March 13, 2001

PARA's Testimony before U.S. Congress

At hearing of public testimony by the House of Representatives Appropriations Subcommittee on Labor, Health and Human Services, and Education, March 13, 2001

Cheryl Miller
Picture of Cheryl Miller testifying before Appropriations Subcommittee
  The Honorable Ralph Regula, Chairman
Picture of Congressman Regula chairing Appropriations Subcommittee

Testimony of Cheryl Miller, Co-Executive Director, Paratuberculosis Awareness and Research Association


Mr. Chairman, thank you for the opportunity to speak on behalf of the Paratuberculosis Awareness and Research Association (PARA), regarding fiscal year 2002 appropriations for the National Institutes of Health (NIH), and the Centers for Disease Control (CDC).

My name is Cheryl Miller. I am from Ohio, and I am the mother of a child that has suffered from Crohn's disease for twelve (12) long years. I am deeply honored and grateful to be here today to represent the people of this nation who suffer from Crohn's disease.

The ravages of Crohn's disease...

Many thousands of times each year, the following scene is played out in medical facilities across this nation:

 

A mother waits. She alternates between prayer and terror, interspersed with sorrow at having watched her child being repeatedly put through some of the most ungodly tests that modern medicine has to offer... endoscopy, barium enema, sigmoid, and now colonoscopy. After what seems an eternity, the doctor enters the room and with great sadness, he quietly states, "I am so very sorry. Your child has Crohn's disease..." In silence and in tears, the mother collapses into the nearest chair. She wants to pick up her child and run away with her to protect her from all of this. But instead, she remains in the chair as the physician continues describing Crohn's, "...INCURABLE... CHRONIC... PROGRESSIVE... DEBILITATING" -- every word a death sentence to all of the dreams she had for her child...

 

Crohn's is a devastating, ulcerating disease that generally targets the intestines. Agonizingly painful, lifelong, chronic and progressive in nature, Crohn's most commonly strikes the young, with more and more young children being stricken every day.

Those of us in PARA are well acquainted with the ravages of Crohn's disease. In contrast to other charities representing Crohn's patients, PARA is not a physician founded and operated organization, rather PARA is a patient-founded and patient-operated organization -- a "grassroots effort" arising from the heartland of this great nation, with renowned physicians and scientists serving in an advisory capacity only. Consequently, those of us in PARA are from the "trenches" -- we live in intimate and daily life and death battles with this vicious disease. And, the truth is that we live in terror. We fear even leaving homes to come here because we never know when our loved ones will need us.

In October of 1997, my husband and I traveled to Louisville, Kentucky to attend a three-day meeting for PARA. We were awakened the second morning by a call from a surgeon telling us that our daughter's intestine had suddenly perforated and they were taking her into emergency surgery. We begged them to wait, but they said they could not -- that she might die if they did not operate immediately. We raced to get home, but we did not make it. Our child was taken into surgery -- terrified -- without even her mother or father there to comfort her.

Considering the experience of only three Members of PARA's Board of Directors or their children, we represent 42 years of vicious suffering from this disease and in just the past 3 years, we have struggled through 22 hospitalizations and 5 major surgeries. During March and April alone of last year, I spent 43 consecutive days in the hospital at my daughter's bedside, not knowing if she would live or die due to complications from medical treatment of this disease. Currently, we estimate that a minimum of $5 billion is spent annually in this nation on Crohn's treatments - treatments which only attempt to maintain patients' lives, but do little to reduce the misery, and do nothing to cure this disease. Those are the agonizing facts of living with Crohn's disease today.

But there is new hope.

I am here today to tell you good news -- for there is great news, wonderful news -- and most important of all, there is now reason for great hope! For the fact is that a rapidly growing and increasingly compelling body of evidence implicates an infectious cause -- a bacterium, known as Mycobacterium avium subspecies paratuberculosis, or MAP -- for Crohn's disease.

Indeed, PARA was formed in mid-1997 because we became aware of the significant evidence suggesting an infectious cause of Crohn's. And, in the summer of 1998, PARA began a series of petitions to the National Institutes of Health (NIH) National Institute of Allergy and Infectious Disease (NIAID) and National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) to consider the mounting evidence that Crohn's may be caused by an infectious agent. In commendation of NIAID, they immediately embarked upon a comprehensive review of the evidence and in December of 1998, Dr. Dennis Lang of NIAID led a workshop in Bethesda, bringing together renowned researchers from throughout the world to discuss the possibility of an infectious cause of Crohn's disease.

Subsequent to this meeting, the NIAID moved quickly and aggressively into the lead to determine the truth about the MAP/Crohn's connection. In May 1999, NIAID published an entirely new and historic Research Agenda targeting an infectious cause for Crohn's disease. In support of and in conjunction with the NIAID, the U.S. Centers for Disease Control (CDC) also issued a Working Document relative to its concern about the need to identify risk factors for human infection. Indeed, we are in a unique situation -- with the NIAID and CDC having determined the research desperately needs to be done and having set forth precisely what needs to be done. Tragically, however, while Crohn's patients continue to suffer, there are still no funding allocations to NIH or CDC to determine the truth about an infectious cause of Crohn's.

The medical community has lost its way.

Led by the long established Crohn's charities/medical and scientific communities, for the past thirty years, research efforts in Crohn's disease have almost single-mindedly centered on intensive study of the "immune system." Sadly, to date, all of this research has yielded little to nothing of benefit to Crohn's patients. Indeed, all of these years/millions of dollars invested in research has resulted in the development of only a single new drug specifically to treat Crohn's disease - and this single new drug provides only partial and very temporary relief for a limited number of Crohn's patients. This drug targets the symptoms of Crohn's, not the cause. I asked before my child was given this drug and was told that based upon trials, the drug effects remission in less than half of Crohn's patients and that the average length of remission was only 12 weeks. My child was infused with this drug on three occasions. On one occasion, the drug provided no benefit at all. After the other two infusions, she experienced only a few weeks of partial relief -- these few short weeks of partial improvement amounted to precious little relief in my child's 12-year-long battle with this miserable disease. Moreover, touted as "new and revolutionary," any potential long-term consequences for patients of using this drug developed partially from "mouse DNA" will not be known for many years to come. The only apparent "bonanza in sustaining benefit" from this single new Crohn's drug appears to be in the billions of dollars to be made in the sale of this very expensive drug to desperately ill patients.

Tragically, while Crohn's patients continue to suffer, it appears that the established, currently funded medical and scientific communities continue, for the most part, to blindly cling to the paradigm that developed many years ago -- a paradigm which insists that Crohn's is some "strange, unfathomable immune system malfunction" -- a paradigm that has persisted in spite of scientific evidence to the contrary and despite the substantial and significant evidence pointing to an infectious cause of Crohn's.

Indeed, as with so many other diseases that have recently been proven to be infectious and not "strange, unfathomable immune system malfunctions," it now appears that Crohn's also may well be caused by an infectious agent -- a mycobacterium. Interestingly, the one unique aspect to mycobacterial diseases such as Tuberculosis and Leprosy is that these bacteria have the ability to cause an intense inflammatory response! Sadly, it appears that Crohn's patients may be suffering because the established medical and scientific communities are caught in a paradigm similar to that Dr. Barry Marshall found when he insisted that stomach ulcers were caused by the bacteria known as H. pylori and not by "stress" or "diet." For twelve long years he tried to tell the established medical and scientific communities, but they refused to listen. Tragically, during those many years the medical and scientific communities refused to listen, ulcer patients suffered mightily, and some died, as a result of this bacterial infection which has now been proven to cause 95% of stomach ulcer cases and the infection is readily cured by antibiotic treatment.

An infectious cause of Crohn's needs to be urgently researched.

Therefore, I come before you today to plead for your help for Crohn's patients. The past 30 years of Crohn's research centering on the "immune response" in patients, has done precious little to ease the misery of Crohn's patients. Meanwhile, we have in our hands scientific studies published in a peer-reviewed scientific journals, the most notable of which determined that long-term remissions in Crohn's disease could be brought about in over 82% of Crohn's patients using a multiple antibiotic regimen similar to that used in the treatment of mycobacterial diseases such as Tuberculosis. These are the best statistics ever seen for the treatment of Crohn's disease, and they were gained using drugs with fewer potential toxic effects than current "immune system" drugs, and using drugs which might even one day effect a cure in Crohn's.

If a disease has an infectious cause, there is a source of infection.

As with so many other diseases for which an infectious cause is now suspected and/or proven, it is time to "break out of this immune system malfunction paradigm" in Crohn's research. It is absolutely critical for Crohn's patients that the truth be found as soon as possible about whether Crohn's is infectious -- for there is another unavoidable and extremely grave consideration involved with our concerns -- and this consideration is urgently related to food safety in this nation.

MAP -- a known pathogen in cattle.

MAP infection causes a disease in cattle called Johne's disease -- a disease that bears striking pathological and clinical similarity to human Crohn's disease. As with Crohn's in humans, Johne's disease in cattle is a systemic disease involving severe inflammation, chronic or intermittent diarrhea, ileum/intestinal involvement, wasting, malnutrition, etc. MAP has also been proven to cause intestinal disease in nonhuman primates. Mycobacteria commonly infect both animals and human beings, and indeed, every other mycobacterium known to science that causes disease in animals has also been proven to cause disease in humans.

In 1996, the USDA reported that 40% of large dairy herds were infected with MAP -- and little to nothing has been done since 1996 to stem the infection rate in U.S. dairy herds.

And, much higher rates of infection are now being documented in some states. For example, a 1998 study found that 66% of 121 randomly selected dairy herds in Michigan are now infected with MAP. Nevertheless, despite numerous pleas from PARA for nearly four years, the USDA has not taken significant steps to stem the infection rate in U.S. dairy herds.

Is MAP in our Food Supply?

It is an undisputed scientific fact that live MAP is excreted in the milk of infected cattle. Terrifyingly enough, nine (9) out of ten (10) scientific studies published in peer-reviewed journals have determined that MAP may be capable of surviving U.S. pasteurization standards. And, scientists have levied significant criticism at the one study that disagrees with the other nine (9) studies, citing a misinterpretation of data by the scientists that conducted the study.

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 U.S. pasteurization standards, this study was again ignored by our U.S. Federal Agencies cognizant of food safety. All in all, during the period 1993 through 2000 -- seven long years -- nine (9) scientific studies came in from the U.S. and around the world which suggested that MAP may survive current U.S. pasteurization standards/practices, and all of them were tossed to the side, ignored by cognizant U.S. Federal Agencies such as USDA/FDA.

Regardless, despite numerous pleas from PARA for nearly four years, the USDA and FDA have not taken measures to exert the precautionary principle in determining whether indeed the food we give our children is free from contamination with MAP.

The U.S. dairy industry now appears to see the "handwriting on the wall"

Relying on the counsel of well experienced and renowned Veterinarians and scientists. the U.S. dairy industry has, for some time, been well aware of the mounting scientific evidence that implicates MAP as the cause of human Crohn's disease as well as the fact that, in the majority of scientific studies, scientists have concluded that MAP is capable of surviving U.S. pasteurization standards. In light of this knowledge, one is not surprised that the National Milk Producer's Federation (NMPF) has suddenly done an "about face" and has rushed to develop a plan to test herds and to kill every cow in this nation infected with MAP. Moreover, it comes as no surprise either that, after many, many years of letting the MAP infection run rampant in U.S. herds, the NMPF has suddenly prepared and submitted its plans to request "indemnity from the U.S. Government in the amount of $1.3 billion" so that these MAP infected cattle are killed and sent to rendering (not for human consumption). Interestingly, this proposed "indemnity plan" looks much the same as those historical indemnity plans developed and implemented to kill all U.S. cattle infected with Tuberculosis and Brucellosis -- both known human as well as animal pathogens. Certainly, these sudden actions on the part of the U.S. dairy industry (i.e. developing an "MAP Indemnity Plan," etc.) should be soberly and duly noted, as they would appear to only further support the potentially grave and critically urgent situation that this nation may likely soon find itself in with regard to possible contamination of our retail food with MAP.

Other countries have taken the lead in food safety.

While our U.S. Federal Agencies ignored the scientific findings, smaller and less financially able nations have 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% of the Gross Domestic Product of the U.S. 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. Late last year, the UK released preliminary results of a study that shows pasteurized milk in the UK contains live MAP.

During this same timeframe, Ireland also stepped to the plate taking dramatic steps to remove MAP from the food chain.

The U.S. must take steps to ensure food safety.

Crohn's is a devastating disease of the young. Interestingly, at the same time that the MAP infection rate has dramatically risen in cattle, the prevalence of Crohn's in the human population has also dramatically increased. Indeed, the Mayo Clinic has documented that the prevalence of Crohn's has increased by 46% since 1980. Currently, there are 20,000 to 30,000 new cases of Crohn's each year in the U.S. alone, with 40% of new patients being under 20 years old. Every day in this nation babies are fed large quantities of milk - milk which may one day be proven to contain live MAP capable of causing Crohn's disease in humans. These food safety concerns must be urgently addressed, lest more and more children in this nation potentially have their lives devastated from this disease.

Failing to act will be costly.

As a further consideration, the dramatically increasing numbers of Crohn's patients, coupled with the "revolutionary" new (and almost unbelieveably costly) treatment, the cost of treating Crohn's disease is skyrocketing in this nation. We estimate that curing Crohn's would result in a minimum cost savings of $5 billion annually in the U.S. Moreover, although the numbers of Crohn's and AIDS patients in the U.S. is roughly equal, currently, $1.8 billion dollars is allocated annually specifically for AIDS research, but $0 (zero) dollars are allocated annually for research into an infectious cause of Crohn's disease.

Summary/Request


At this most opportune time, with medical science potentially on the verge of finding the cure for Crohn's disease, it is critical to address these issues with utmost urgency. What is most urgently needed now is the funding. Mr. Chairman, to address these urgent concerns, we ask the following:

Request to the Labor, Health and Human Services and Education Subcommittee
  • Request that a formal "Crohn's Disease Program" be developed and implemented at NIAID, and allocate $300 million in new funds to NIAID to complete its historic and urgent new research agenda targeting an infectious cause of Crohn's disease

  • Request that a formal "Crohn's Disease Program" be developed and implemented within CDC, and allocate $200 million in new funds to CDC to complete its agenda to identify risk factors for human infection with MAP

  • Request that Crohn's disease be identified as an Emerging Infectious Disease, and that it be treated with the utmost urgency

  • If possible, encourage those Congressional Committees cognizant of food safety to immediately begin addressing the food safety issues associated with MAP in retail food supplies in the U.S.

In conclusion, Mr. Chairman, please allow me to thank you on behalf of the Paratuberculosis Awareness and Research Association for hearing our request and for your consideration of these most critical concerns facing Crohn's patients, as well as this nation as a whole.

References


Submission to Congress: "Request for Earmarked Funding Allocation for Research Targeted at Infectious Cause of Crohn's Disease"


Source: http://www.crohns.org/media/rp010313.htm   Contact PARA: http://www.crohns.org/contact.htm
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