This is really not the most desirable way to start a new year. It was also especially discouraging because neither of the two ANPRs was really characterizing the current science of risk analysis associated with an outbreak of BSE in the United States, the philosophical nucleus of the ANPRs. This, therefore, surfaces the question, why did it happen? Surprisingly, a part of the answer was in a book written about two years ago by Matt Ridley, a former science editor, Washington correspondent, and U.S. editor for the Economist. In his book, Genome, Ridley provided an exciting voyage and fascinating tour of the world of chromosomes and genes, and how these “molecules” influence disease, and, indeed, the future of medicine.
In Genome, Ridley, instead of using chapters as traditional writers do, resorted to an especially innovative approach to fit the thematic philosophy of his publication by using chromosomes to depict what is normally conceded to be a chapter in standard publications. In Chromosome 20, under the title of Politics, he went ahead and described BSE, and by inference, variant Creutzfeldt-Jakob disease (v-CJD), and reminded his readers that esoteric knowledge has a habit of changing the world, as evident by the BSE linkage to v-CJD, which also “became one of the most incendiary political issues in science one day in 1996,” all associated with an unconventional infectious agent, first described by Stanley Prusiner of the University of California, San Francisco, as a prion. Prusiner subsequently won the Nobel Prize in Physiology and Medicine for his characterization of this new novel infectious agent and his overall contributions to neurological research.
For the historical record, that day in late March 1996 alluded to by Ridley will always be deeply entrenched in my memory because it was the beginning of a series of risk characterization in the United States that haunts us to this day, perfectly exemplified by the two ANPRs that were alluded to in the first paragraph. Emergency meetings then became the norm and it was not unusual to get 50-60 calls a day at the National Renderers Association headquarters in Alexandria, VA, on varying issues of the elements of risk. The rendering industry was forced to defend its practices. During the same period, Armageddon-like statements began to be made in the United Kingdom by reputed medical scientists about the potential for human mortalities into the millions. Even relatively logical thinking and very responsible people in the United States started to project doubts about the safety of animal proteins, and a series of rabid defenses of the industry’s historical record of safety had to be made. In essence, we pled for fairness, and, at times, simply asked critics and concerned parties to look at the record objectively of products that have been used in the United States for over a century without adverse incidents.
But, let us revert to Ridley’s contention about BSE and the prion diseases and determine whether or not it is prima facie evidence of politics. That assessment could have varying degrees of opinion, and each person should come to his/her own opinion independently. On a personal level, I totally agree with Ridley’s linkage of BSE and politics. I have never seen a group of diseases in my 40 years association with regulatory medicine and policies that have become so enthralled in politics like the prion diseases. Even the advanced technologies in North America do not seem to be exempt from the pressing influence of politics on the theories of risk analysis. An objective and fair examination of how chronic wasting disease (CWD) was handled in Wisconsin clearly demonstrates the problem of political interferences that did not contribute to either solutions or resolutions of the issues. All of this in a country that the most comprehensive assessment of risk, done by one of the most prestigious academic institutions in the world, Harvard University, is still debated, in spite of the summary analysis, “that finds the United States is highly resistant to any introduction of BSE or a similar disease. BSE is extremely unlikely to become established in the United States.”
Logically then, assuming that any inference to the prion diseases and policy can amplify logic, what is happening and why are two government agencies so intent on pursuing regulatory considerations that seem to be a total overkill? The answer is really linked to the uncertainties of the prion diseases, and the fact that government agencies acting in the quest to protect animal and human health have elected to be ultra-conservative to a point that approximates no risk. There are many reasons for this approach and a debate can continue indefinitely on the pros and cons.
But, be advised, that many excellent scientists in government service are fully convinced that the analyses made by our own epidemiologists about BSE, and the Harvard report of an “extremely unlikely” incident are reflective, and they are reasonably comfortable with the existing policies that have worked well for the country. On the other hand, there are still elements in government that fear the unknowns associated with the prion diseases, even in an environment of very limited risks, and feel that there is still reason for varying degrees of caution. In government, there seems a definite inclination to follow the protective coat of caution. It protects decision makers and contributes to the appearances of safety that make politicians reasonably comfortable.
An agency, we must all remember, is nothing more than a multi-appendaged creature with some tentacles that tend to invite external sources into its decision-making processes, while other appendages will often push back and often deny such form of intrusion. Basically, the issues and the considerations normally determine whether an agency will “push” or “pull” in looking at its options. The two ANPRs of the different agencies allow everyone to push or pull while expressing their comments to influence change. It often works, and is appreciated by agencies because the notices provide a semblance of reference information submitted by us all that can protect, if needed, the decision making process of the agency.
In closing, as I look at the frustrations that we all face, the industry, the government, the public health establishment, the decision makers, and, indeed, the politicians, I am comforted, nonetheless, by words of Mark Twain that could hopefully help us all maintain our composure: “Predictions are very difficult to make, especially when they deal with the future.” As a student of Twain’s writings, all I can say is, only Twain! It certainly reflects the complex nature of the prion diseases, and the nuances of the decision-making process that confront us all on a daily basis.
Tech Topics - April 2003 Render