stries," says Kennedy. "So they suffer from CJD – conflicting job description."
"We have been asking that the retail milk supply in the United States be tested for the presence of [Mp], and they [FDA] refuse to do it," says Stephen Merkel of Cleveland, a founding member of PARA, whose wife has suffered with Crohn's disease since 1960. "They insist that this organism does not survive the pasteurization process. If they're so sure, why not test retail milk? I see only one explanation as to why they refuse to test the milk supply -- they are afraid of what they might find."
Despite the repeated beating of their collective head on the proverbial brick wall, PARA achieved a major breakthrough when they successfully lobbied the National Institutes of Health to conduct a workshop on Crohn's disease in December 1998.
"We went out to the NIH and implored them to look at the science," says Cheryl Miller of Dayton, also a founding member of PARA, whose 5'6" daughter was down to 92 pounds before she began taking an antibiotic regimen similar to Hermon-Taylor's, which was followed by her rapid improvement. "The NIH reviewed the science and put on this workshop. The fact that the NIH took this action tells you that a prudent person aware of the available scientific evidence would be very, very concerned."
The research battle
On Dec. 14, 1998, a host of researchers were brought together at NIH in Bethesda, Md., to discuss the possible connection between Mp and Crohn's. Despite the circumstantial evidence that there exists a relationship, it is hardly a forgone conclusion. Among the impressive group of experts presenting evidence of a possible connection, one presenter took the opposing viewpoint.
"If you had talked to me in 1984, I would have given you the same kind of pitch that Mike Collins gave," says Dr. Herbert Van Kruiningen of the University of Connecticut. "I would have shown you a picture of an emaciated cow, an emaciated human with Crohn's, and I would have shown you a picture of the intestine of a cow with Johne's and a human intestine with Crohn's.
"But in the meantime, an awful lot of evidence has come by, and I would be no damn good as an investigator if I didn't accept that evidence from lab after lab after lab. I made a decision a few years ago that I wasn't going to spend the rest of my life chasing Mycobacterium paratuberculosis when all of this evidence is out there that this isn't the correct organism."
Kruiningen -- although at the same time admitting that Crohn's research has been woefully underfunded -- cites examples of researchers' failed attempts, including his own, to establish a connection between Mp and Crohn's.
"When you have low-budget research, you get low-budget results," says Chiodini. "Most scientists appreciate that negative results are easy to achieve. It is the positive results that take effort."
"It's very hard to prove causation," says Collins. "Critics are fair to say it's still just an association. It's a very complicated disease, and it's a very complicated organism to deal with."
Kruiningen, undeterred in his opposition to the theory, wrote to Dr. Dennis Lang, who helped to organize the NIH workshop, shortly afterwards. "I came away [from the Crohn's disease workshop] with the impression that the M. paratuberculosis proponents had carried the day. It appeared that most of the people there were enamored with the interesting hypothesis, to the point that data to the contrary were secondary."
Despite Kruiningen's objection to the theory, the NIH workshop produced a document concluding that research into the possible connection was not only warranted, but necessary. Lang says that a wide net will be cast in looking for a cause of Crohn's, but most of the research recommendations that were made in the NIH document involve various aspects of Mp and its potential to cause Crohn's disease in humans.
Interestingly, every single NIH research recommendation had been made by Chiodini in the form of grant proposals between 1984 and 1994. Yet despite Chiodini's work -- recognized by those in the field as v