September 4, 1997

TO:
The Honorable Winston Peters
Deputy Prime Minister

FROM:
Dr. Alvin W. Smith, Head
Laboratory for Calicivirus Studies

RE: Question of Legalizing and Spreading the Rabbit Hemorrhagic Disease Agent in New Zealand

It is my understanding that this coming Monday, 8 September 1997, the New Zealand Cabinet will meet to consider the legalization of rabbit hemorrhagic disease in New Zealand. This action is not being taken because the questions regarding RHD that needed to be answered have been answered, but because there is now a need to make legal a series of illegal acts. Please consider with your government leadership the following points:

1. The virus in Australia has proven to be so unreliable as a biocide for rabbits that the Chief Australian proponent for its use, Dr. Brian Cooke, is now reported to be recommending that spread be discontinued in Australia. His stated reasons are unreliability of the agent, but one can "smell" something else. Renewed uncertainty or overt evidence of non-target species or human infection would be a much more compelling reason for halting the spread than a reduction in effect on rabbits.

2. Already Lockwood Smith is lobbying for a more deadly strain of virus. Doesn't he know that the Australians do not yet know enough about their RHD virus to separate out strains on the basis of kill rates? In fact, two years ago the proponents were adamant that the virus would not mutate and now they are relying on mutation to "fix" their broken program.

3. Is there no concern that New Zealand will now live eternally under the cloud of yet another poorly defined and sometimes deadly agent which is not having the intended lethal effect on target species. Future effects on other species are simply unknown. And is there a failure to understand that by purposeful spread, the exposure doses which all non-target species are subjected to will increase by orders of magnitude, thus greatly increasing the mathematical odds of transmission to non-target species, including humans? (For more detail, see Attachment 1.)

4. Do we hear Dr. O'Neil assuring people how safe the virus is for them and their pets, when just 30 days ago Dr. O'Hara was telling New Zealanders that one reason he did not approve RHD was that it "infected" dogs in Europe? We can't have it both ways no matter how skilled and determined the spin gets. Remember, in the beginning, if the virus was to infect any non-European rabbit species, it would be disqualified as a biologic agent. The risk assessment was to evaluate aspects other than infection of non-target species.

5. Which of the long list of questions that were to be answered before import approval could be granted have now been answered? None, of course. The only added data point is the seemingly poor effect and spread in New Zealand, and that certainly is not justification to legalize the spread.

6. Using the Freedom of Information Laws, additional data has been forced out of the CSIRO and other Australian entities regarding human tests. The disquieting facts from this are that the tests are totally unreliable when used on human sera and any report that exposed humans did not develop antibodies is NOT substantiated by the data. In fact, one cannot tell whether they did or didn't. Consider the following statement from Dr. Mike Catton, Medical Virologist, who reviewed and reported the results of human serologic testing. "Each sample was tested in duplicate by competitive ELISA and the mean of the two results recorded. If there was poor agreement between the two readings, the serum was retested." Now if we look at individual serum samples from 1013 serums pulled from a serum bank in Australia for the purposes of standardizing the test before it was used, we see the following results and there are many more such examples (see Attachment 2 for complete data):

Individual serum #64 - four tests range from 4 to 38 percent inhibition

Individual serum #112 - five tests range from 16 to 47 percent inhibition

Individual serum #173 - six tests range from -6 to 23 percent inhibition

Individual serum #184 - four tests range from -5 to 53 percent inhibition

Individual serum #383 - four tests range from 8 to 87 percent inhibition

In other words, it seems that the laboratory kept testing until they could get two readings that were low enough and close together, then used the mean of these two tests as the reported value. The numbers were treated as political prisoners and simply tortured until they gave the needed answers. Look at the above results and remember that anything above 30% inhibition is supposed to be positive. In other words, many sera were positive when it was known that they were collected "before Australia had RHD." In short, the serologic tests are unreliable for testing humans and virtually all other non-target species. Yet New Zealand would consider legalizing a disease that cannot even be studied epidemiologically in exposed humans or other non-target animals.

7. No one tells us WHY there are no reports of disease in non-rabbit species. If infections had occurred, the tests to diagnose such occurrences are unreliable and there is a reluctance to use them. When we are told that no disease has been reported in non-rabbits or in humans in 40 countries, we must insist that the survey data be included. How many ill people and animals in contact with sick rabbits were actually tested, what tests were used, how reliable are the tests, where is the data? The data simply does not exist in reliable form anywhere in the world including Australia, and there is a great reluctance, particularly in Australia, to do these critical tests or to share with the public the entire findings on what little testing has been done.

8. There is one additional point that must be made to show how deceptive the human health study data reporting has been. Dr. Catton also states, "the cutoff was not raised to 50% for humans. When we commenced the study, a 50% positive cutoff was the standard configuration for the RCV competitive ELISA for use with animal sera. We elected to use the test for humans exactly as configured for animals...and the protocol was widely accepted in the public domain." The protocol Dr. Catton refers to is a 30% cutoff, not a 50% as he stated, and he had to know that. A much more likely story is that the cutoff was raised above 50% because too many human sera in the 1013 tested for baseline gave reading on some tests approaching 50% and occasionally higher. Again more numbers tortured to keep them from reporting an unwanted finding.

9. There is an additional point to be made from Dr. Catton. He says, "a 50% cutoff is in my opinion perfectly acceptable and comparable to other competitive ELISAs in use on human sera, for example, the Wellcozyme HIV ELISA." This test is used to test an individual for AIDS when one needs to be very sure to not say they are positive when they are not. In other words, one will allow some positives to test negative to preclude making a false positive diagnosis. On the other end of the spectrum, where there is need to identify every positive, for instance in blood donors, if Dr. Catton used the same 50% cutoff to test the donor blood supply for AIDS, the entire county would be flooded with blood positive for HIV antibody. To insure that every positive was detected, the threshold would be dropped to maybe 5%. Such sleight of hand as demonstrated by Dr. Catton's 50% cutoff permeates the entire RHD applicant process where truth, safety, risks and unknowns of RHD have been left "blowing in the wind" for the purposes of a few people bringing to fruition a high-risk program based on wishful thinking and no scientific substance.

Finally, I must point out that the virus does not work well for the intended purpose. Now the government's responsibility has surely shifted to insure the safety of its people. Please do not attempt to create epidemics in rabbits and thereby increase the risk of deadly disease spilling over into non-target species, including the people of your fair nation.

cc:
The Right Honorable J.B. Bolger, Prime Minister
Dr. Gillian Durham, Minister of Health
Honorable Nick Smith, Minister of Conservation
Honorable Simon Upton, Minister of Biosecurity
Professor Bruce Ross, Director General of Agriculture

Attachments:
1. Rabbit Hemorrhagic Disease Fact Sheet (4 pages)
2. Laboratory Record Sheets from CSIRO giving serologic results on 1013 human serums

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