Dear Mr. Smucker:

I am writing this letter to both the F.D.A. and U.S.D.A., the agencies charged with the responsibility of ensuring that the milk supplies of our country are safe for the American consumer. It is clear to me from telephone conversations I have had this past week that there is no way to determine whose ultimate responsibility it is for this matter, whether it is the F.D.A. or the U.S.D.A. Frankly, that is not my concern, and the bureaucrats can decide that at a later date. What I am interested in at this point is getting to the bottom of a situation that, in my opinion, has serious consequences.

First, I would like to give you a little background on events preceding the writing of this letter. My 22-year-old son has Crohn's Disease, having been diagnosed at the age of 17, a time in his life when he should have been ready to conquer the world. Instead, in the last five years he has had four hospitalizations, undergone a surgery to remove two and a half feet of his intestines, endured medical procedures, consumed countless medications and has had to deal with the understandable depression that exists for most patients with this disease. The year he was diagnosed, his senior year in high school, our lives changed forever. But this letter is not meant to evoke your sympathy for our family but to incite you to take action that may prevent this from happening to other families, indeed your family.

Three weeks ago I became aware of information that led me down a path to search out a "cure" for my son. On that path I discovered some things that disturb me even more than the disease that has robbed him of his youth. One of those things I have discovered is that, in fact, there has been considerable research done over the past ten years linking Crohn's Disease to Mycobacterium Paratuberculosis, that this is in no way a recent discovery. There has been a great deal of medical and scientific literature published on the subject. The next thing I discovered is that there is a considerable amount of evidence to link Crohn's Disease to Johne's Disease in cattle. The most disturbing thing, however, is learning that many people in this country are aware of the problem, yet those people have made no attempts to aggressively research this issue.

In my conversations with various individuals of both the U.S.D.A. and F.D.A., your representatives have assured me that pasteurization, in fact, kills 100% of Mycobacterium Paratuberculosis. According to scientific research and studies that have been conducted by leading authorities on this subject, there is evidence to suggest that this bacteria is indeed present in pasteurized milk, that pasteurization does not kill all of the bacteria. I would assume your experts are privy to the information I as a lay person have been able to access in three short weeks, at least I would certainly hope so.

Among the information I have found are the following quotes and studies: "Research done at Ohio State University has shown that you can still culture some Johne's bacteria from contaminated milk AFTER PASTEURIZATION." This is a statement made by a professor at that university. In addition, there was a study completed in England and published in September, 1996, by Professor Hermon-Taylor and his colleagues which found that despite pasteurization, MParaTB was found in 7% to 25% of the retail milk supplies. Interestingly enough, the percentage rates coincide with Crohn's Disease patients' flareups.

If these two things don't get your attention, perhaps two recent '96/'97 studies conducted by the U.S.D.A. itself will. I will quote from each.

First, "Recent reports suggest this organism is causally associated with Crohn's Disease...Although this association has yet to be established conclusively, the potential for human exposure to this organism through consumption of foods from cattle...is of considerable food safety and public health concern...Approximately 25% of dairy herds have Johne's Disease and up to 50% of animals within a herd may be infected...There is also evidence that MParaTB can survive conditions simulating standard pasteurization processes, suggesting that retail pasteurized milk may also constitute a potential risk for human exposure."

Second, "Contamination of meat with feces or milk at slaughter represents a potential source of human exposure to MParaTB. Furthermore, ground and deboned beef produced largely from cull dairy cattle are more likely to be contaminated with this organism than prime cuts from fat cattle."

When I presented these two studies to your representative at the U.S.D.A., of course, his response was there is no conclusive evidence at this time. As a matter of fact, he used a statistic to support that statement: In a survey of gastroenterologists, 80% of them believed there was no connection between MParaTB and Crohn's Disease and 20% believed there is a connection. I submit to you that reasoning is flawed in that the more qualified individuals to answer that question would be researchers, not physicians who rely on researchers for their answers. In addition, it would be of no value to poll a group of doctors who also ridiculed for ten years the discovery by Dr. Barry Marshall that indeed a bacteria, HPylori, was responsible for most ulcers. In 1994 he was proven correct in his theory. Thankfully for the ulcer patients, Dr. Marshall was tenacious and now 85% of ulcers are cured by two weeks of antibiotic therapy.

With regard to transmission of the disease from cows milk to humans, when I expressed my concern to your representative that calves are not even allowed to suckle the dams at birth for fear of exposure, he assured me that was a purely economic decision on the part of farmers, that they did not want to lose even one milking session with that dam. Well, again, I do not agree with his answer, and let me cite again for you some evidence contradicting that statement.

A quote from an Extension Dairy Agent to a question posed by a dairy farmer about use of whole milk replacers to calves: "....If your herd has Johne's Disease, you should not feed whole milk as Johne's Disease can be passed through the milk."

The quote that carries the most weight, however, is one made by Dr. Michael Collins, the leading authority on Johne's Disease, in his "Johne's" web site at the University of Wisconsin: "MParaTB infections can be transmitted from mothers to offspring by contact with the mother's infected feces, through infected colostrum or milk from the mother or across the placenta into the fetus before the baby is born." Again, this was in a section dealing with control of the disease, giving information to the farmer on how to control the disease.

I submit to you that if it is common knowledge among dairy farmers not to allow the calf to suckle the dam, then why is that same dam allowed to give milk which will end up in our children's glasses of milk we encourage them to drink every day? I am only making what I think are logical deductions from the points mentioned above. If (1) the bacteria is present and can be transmitted in milk, and (2) pasteurization does not kill the bacteria, then what else can we assume except that we have a major problem? If not, I challenge you to give us answers that make sense.

Again, I am no expert, but it would seem to me there are several things our government needs to address immediately. In an abundance of caution, our government needs to conduct random sampling of milk supplies in our country to determine whether, in fact, MParaTB is present. That would assure consumers that it is indeed safe to consume milk products. To avoid the appearance of conflict of interest, I would suggest that this research team be composed of a variety of researchers, those tied to the dairy industry, those from the F.D.A./U.S.D.A., and experts who have studied MParaTB for many years, Dr. Rodrick Chiodini, Professor John Hermon-Taylor or individuals of their choosing. We must have an unbiased study conducted immediately.

Secondly, our government needs to do more than give "lip service" to this issue in terms of research. The monies that have been spent on this issue are pathetic in comparison to the potential for disease among the population of our country. I am sure experts on both sides of this issue will agree that we are never going to get a conclusive answer until proper research is conducted, something that has not been attempted heretofore. The leading expert on MParaTB has suggested that we need $20 million to properly answer this question of safety and study the issue properly. One only needs to watch NBC Nightly News' segment "The Fleecing of America" to realize that much more than that figure is wasted every day. I can think of no better way to spend taxpayer dollars than in taking measures to protect our health. It is estimated that Crohn's Disease costs 1.2 billion dollars annually; that $20 million could be recouped in three months based on those figures. I would consider that a worthwhile investment.

I am not naive when it comes to the economic impact this matter will have on the dairy and cattle industry, a thought that I am concerned about as well. No doubt that if this problem had been properly addressed years ago, you would not find yourselves faced with the dilemma you are faced with in choosing between great economic ramifications for a large industry or public safety. But when we as a nation decide that economic impact outweighs human welfare, then we are all in trouble. While the experts are playing a "wait and see" game, 30,000 more Crohn's patients, primarily ranging in age from 15 to 25, will be diagnosed in our country this year alone. The 2,000,000 sufferers of this disease could, in fact, be exacerbating their condition by continuous introduction of this bacteria into their bodies on a regular basis. They don't have time to play a waiting game. Just as Johne's is called the "wasting disease" of cattle, Crohn's Disease is a "wasting" disease in humans. These people have "wasted" long enough!

In the same conversation I had with the U.S.D.A. representative I asked him why our government was not insisting on an aggressive program to control this disease. His answer was that the government's position is and has been that the government prefers not to regulate any more than necessary, and that it is in the best interest of everyone to have an "industry driven" program. Well, my answer to that: Is the fox guarding the hen house? I agree with the conservative philosophy that "less is better" when it comes to government intervention in business, but NOT WHEN IT ENDANGERS HUMAN LIFE. At what point will our government step in to elevate public safety over industry considerations?

When I informed him that news media people were already involved in this issue and that this was a problem that was not going away, the impact of the answer he gave did not have full significance for me until later. His response was, "We've been expecting this for two years. We're ready." What does that mean? I can only imply from that remark that "they" are expecting adverse publicity, and that "they" are prepared with a plan of damage control for negative publicity. I hope that is not the case. Surely the last two years could have been better spent in looking for real answers instead of doing "damage control." If that is the case, I think "they" really miscalculated their strategy. When you are dealing with people who have chronic disease and who are going to learn that possibly it could have been avoided or at least lessened by precautions having been taken years ago, those individuals will soon become a very large group that will cause this plan to backfire, probably explode in "their" faces.

I have been in touch over the last several weeks with quite a few people who have Crohn's Disease that are just as concerned as myself over this situation. There are 2,000,000 individuals in this country alone that have Crohn's Disease, and not only are they affected but their families. It would be safe to assume that 10,000,000 people are greatly interested in this issue. I think I can speak for all of them when I say we want answers, and we want them now. Many of these individuals don't have the luxury of waiting while the government conducts more research and studies the matter for several more years, while the dairy and cattle industry decides whether it's economically feasible to aggressively control this disease.

Our government's position should be that in an abundance of caution, it will do everything in its power to protect its citizens. Time is of the essence for sufferers and potential sufferers of this disease which is why an immediate response to this is critical. In light of the fact that "they" have been ready for this for two years, it should be no problem in furnishing a response to this letter within ten (10) days. This is a matter that will be of great interest to the public at large since none of us know when we or our children will be stricken with this disease. I implore you to take measures to protect all of us. While I am doubtful you will offer concrete answers to my questions, I am nevertheless attempting to get those answers so that it will be "on the record" the position you are taking.

None of the officials I spoke with in the last few weeks have known any Crohn's Disease patients. To enlighten them and you, I have enclosed a heartbreaking story from the mother of a 24-year-old young man who was stricken with this disease only eight months ago. He had just graduated from college and had everything to live for. I want you to read in detail the summary his mother gave to me of what their life is like now, of what this young man has had to endure. Knowing politics and economics are at work in this issue, I want to now appeal to your humanity. If you can read this account and not be moved, then God help you! Unfortunately, this young man's story is not unique. In fact, this could be your son or daughter next month, next year. None of us know when it will strike. We didn't. Even though the position taken in this letter will not be popular with many individuals, it is something that will benefit even those who are the most avid critics of it.

In closing, I would like to quote from Dr. Rodrick Chiodini, the doctor whose life's work has been study of Mycobacterium Paratuberculosis and Crohn's Disease: "Unfortunately, if this hypothesis is ultimately proven correct, many patients may have unnecessarily endured continued suffering, not because of science, but because of the controversy created." Please put an end to the controversy and seek out real answers.

Sincerely,

Karen Meyer

Dear Mr. Smucker:

As I am sure you are aware, a policy analyst from the FDA replied to my letter addressed to you on May 31, 1997. Over half of the reply was devoted to a detailed explanation of why the previous studies were flawed because they did not accurately simulate the HTST commercial method, and yet Dr. Stabel's study indeed "simulated" that method of pasteurization. Why "simulate" anything? Why not use an actual commercial pasteurizer and test actual milk supplies?

It appears that both the USDA and FDA are putting great emphasis on the study of Dr. Judith Stabel concerning whether pasteurization kills M. paratuberculosis. Not being a scientist, I have sought out the advice of some experts who have given some insight into the study by Dr. Stabel that your agency and the USDA are relying on so heavily to ensure the safety of milk supplies in the U.S. I will briefly touch upon the criticisms of her study based on the information in her abstract:

(1) Dr. Stabel's study has not been published. Unless data is published in a peer-reviewed journal, it is not subject to critical review of the methods or data.

(2) Laboratory conditions do not accurately reflect commercial operations regardless of how attempts are made to simulate them. The USDA had and has access to the use of actual commercial pasteurizers.

(3) Laboratory strains do not accurately represent wild strains and may respond differently in studies than "in vivo" grown organisms.

(4) The low bacterial counts used by Dr. Stabel were below the detection level of the methods used, i.e., the numbers were so low that they could not have been detected even if alive.

Apparently her study has been submitted for publication which, as you know, does not mean it will, in fact, be published. But in the event it is, certainly scientific protocol would dictate that it should be subjected to the same scrutiny by critics that was devoted to the study by Dr. Hermon-Taylor. Until such time that it has been analyzed by others who are expert in the field, I think it is rather reckless of the USDA/FDA to rely on this study to ensure safety of the milk supply for the entire country. There is too much at stake in terms of human health for our government to do any less than demand that valid studies are conducted, those that fall within the parameters of scientific protocol for publication and peer review.

Obviously, there are two schools of thought that exist on this issue. There are those who are "pro" association between Johne's and Crohn's and those who are "anti" association between Johne's and Crohn's. Those who are "pro" are leaning towards Dr. Hermon-Taylor's study as being valid, while those who are "anti" are relying on Dr. Stabel's study as being valid. I am certainly not qualified to give opinions on why Dr. Hermon-Taylor's study is scientifically sound. But the fact that the study was evaluating the actual retail milk supplies certainly seems a better way to find out contamination levels as they exist in the real world as opposed to a laboratory study which only makes the assumption that everything done within that small setting holds true for the thousand or so pasteurizers that exist throughout the country. I am not comfortable with putting my son's entire future on the line because of one laboratory study.

Along that line, everyone I tell about this situation within just a few minutes poses this question to me: "Well, why doesn't somebody just test the milk?" That is a very logical deduction when considering this question. Wouldn't that be the only real way to know for sure whether the thousands of pasteurizers in this country are indeed adequately killing this bacteria? How else will we ever know? A laboratory study is just that, a laboratory study.

Obviously, there are abundant contradictions concerning the etiology of Crohn's Disease and the role that M. paratuberculosis plays. I doubt anyone would disagree that a primary reason we have no conclusive answers on any of the issues involving the relationship of M. paratuberculosis to Crohn's is the fact that totally inadequate funding has been available. Apparently it is a problem that is not going to be aggressively addressed until it can no longer be ignored. The problem of inadequate funding will be addressed in a different forum.

Since Dr. Collins' research has been extended by Crohn's Colitis Foundation of America (CCFA) for two more years, we can be pretty sure that there will be no conclusions drawn on the relationship of M. paratuberculosis to Crohn's until that time, and even then, answers may not be conclusive. In the meantime, at least two more years of suffering have been endured by patients who already have the disease, whose conditions may be exacerbated by continually reintroducing this bacteria into an already diseased gut. In that two-year period tens of thousands of new cases of Crohn's Disease will be diagnosed, a majority of whom will be young people. I might add that many experts believe that the true prevalence/incidence rates of Inflammatory Bowel Disease (both Ulcerative Colitis and Crohn's Disease) is extremely underestimated given the nature of the disease and the fact that many people go into years of remission. This is a disease that affects many more people than is statistically reported.

It is a very real possibility that even then there may be no definitive answers. Does that mean that just because no link is established that we ignore the fact that this bacteria is possibly in our foods? Is it your position that it is an acceptable bacteria for human consumption? I think that is a very important issue here. If it is not an acceptable bacteria for human consumption, WHAT ARE YOU DOING ABOUT IT NOW, AND WHAT DO YOU INTEND TO DO ABOUT IT IN THE FUTURE?

Until answers are found, our government should immediately begin a testing program of the retail milk supplies of the United States. Dr. Rod Chiodini, the leading authority on M. paratuberculosis, in his paper of Fall 1996, at the International Colloquium, entitled "Debate: M. paratuberculosis in Foods and the Public Health Implications" has proposed an excellent program to accomplish this:

1. Assemble a group of scientists representing the veterinary, medical and food sciences to organize the study, the objectives, and goals. This committee must be devoid of all regulatory, political or non-scientific individuals and represent a scientific "think-tank." Politics has no place in the development of scientific protocol. It must be a non-biased committee, representing the best minds with the most experience and knowledge in all appropriate fields. Since truly unbiased individuals do not exist on this issue, both extremes must be represented. The committee members should be paid for their efforts to insure the ability to recruit the best individuals for the job at hand.
   
   
2. Go to a university or other institution that has their own commercial pasteurization unit, and through the assistance of regulatory and other appropriate individuals, take over the pasteurizer for a few weeks to perform all studies in a bona fide commercial pasteurizer. There are few universities that would deny the industry this opportunity, particularly if they agreed to pay for its use and/or to compensate the university for lost income during its use. Studies could be performed and regulatory agencies could then clean up the pasteurizer and put it back "on-line," a simple solution to get around the laboratory artifact issues.
   
   
3. With protocols in place (defined in step 1), solicit proposals to perform the following studies:
   
   
   1. Determine if M. paratuberculosis survives pasteurization in a full scale commercial pasteurizer. These determinations must include, in addition to laboratory spiked samples, milk from cattle actively shedding M. paratuberculosis in their milk. Detection methods must include PCR as well as the best available culture methods including filtration and other concentration techniques to maximize sensitivity of the assay. Simple cultivation, with a detection limit of >100 cfu/gm or more, is appropriate.
      
      
   2. Determine if M. paratuberculosis exists in the retail milk supply in the United States and whether or not they are viable. Again, detection methods must include PCR as well as the best available culture methods including filtration and other concentration techniques to maximize sensitivity of the assay. Simple cultivation, with a detection limit of >100 cfu/gm or more in feces and unknown in milk, is appropriate. Sensitivity must be well defined so that negative survival results are within detection limits and not below.
      
      
   3. Proposals need to be evaluated and considered irrespective of cost -- a scientifically sound study cannot be performed on a "shoe-string" budget.
      
      

The cost of implementation of this program would be equivalent to the cost of one "Got Milk" commercial during Super Bowl, less than a million dollars, and we could have once and for all answers in one year whether indeed M. paratuberculosis is finding its way into our retail milk supplies. Certainly, the lives of the sufferers of this disease warrant that type of investment by the U.S. Government and/or the dairy industry. In the future if no relationship between M. paratuberculosis and Crohn's is found, then what has been lost except some money? On the other hand, if nothing is done and a relationship is proven, then how many people have suffered needlessly, and who is going to take responsibility for that?

Since my initial letter to you, an organization of concerned Crohn's/Ulcerative Colitis patients and significant others has been formed. Our numbers are not great at this point, but our resolve is. We are looking forward to a response from you addressing our concerns set forth in this letter. My family, along with the others who live with this disease every day of our lives, await your reply.

Sincerely,

Karen Meyer

/km