The Lombardi study
was blinded (although Alter/Lo was not). Lombardi and Mikovits made clear the fact that their study was blinded in their response to comments in Science magazine. It's extremely difficult to believe that McClure had not read that published response, so I would classify her response to cfssufferer as deliberate misinformation. Cfssufferer has already edited his blog to correct this information, btw; it now reads:
Professor McClure has stated that the Science and PNAS papers had “CFS samples and control samples (that) have not been blinded, randomised and treated in exactly the same way at the same time.” This argument is used by Professor McClure as a potential mechanism to explain how the CFS samples were contaminated while the control samples were largely unaffected. Professor McClure has falsely associated these non-procedures with the Lombardi et al. paper as explained by Mikovits et al. in a ‘technical comments’ addendum to the Science paper. Mikovits et al. state that “All samples were blinded, as mandated by the NCI and WPI institutional review board approvals. All experimental procedures were done by the same personnel, in the same physical laboratory space, under identical protocols. Investigators at NCI received 100 samples from individuals without knowing their health status; furthermore, the samples were sent to NCI directly without passing through the WPI laboratory space. Laboratory workers at the NCI and the WPI who performed the polymerase chain reaction (PCR) and immunological studies used coded, blinded samples that did not reveal the CFS status of the individuals.” These technical comments can be found here
http://www.sciencemag.org/cgi/content/full/328/5980/825-d
Professor McClure has erroneous information concerning this crucial aspect of the Lombardi et al. study. Contrary to Professor McClure’s assertion, the CFS samples and control samples in the Lombardi et al. study were in fact “blinded, randomised and treated in exactly the same way at the same time.” McClure’s contamination argument seems largely contingent on her erroneous piece of information. With this new information, Professor McClure’s conclusion that the “weight of evidence indicates laboratory contamination” is further jeopardised. If Professor McClure is to maintain her contamination hypothesis, she must now provide a mechanism explaining how contamination occurred in only the CFS sample subset that was part of the larger set of blinded and coded samples that were treated in an identical manner.
Professor McClure is correct in that the Lo et al. study was not blinded or randomized. Dr. Alter has explained that “We did not specifically blind and mix the two sample groups (CFS and blood donors.) However, they were studied in parallel by polymerase chain reaction (PCR).” Dr. Alter’s assertion that the samples were “studied in parallel” is reiterated by the Lo et al. paper itself which states “PBMC DNA (30–40 ng) from the CFS patients and the healthy blood donors, as well as serial dilutions from 50 to 1 fg of mouse DNA mixed with 35 ng of human DNA as the positive templates, were tested in parallel.”Another section of the Lo et al paper says, “All patient and control samples were coded and tested in parallel.” If both the CFS group and control group samples were tested as part of a continuum in a random sample order then the contamination likelihood is very small.
Anyway, this is another outstanding article by cfssufferer, and I highly recommend reading it to anyone who has not. I made the following comments about McClure's email on mecfsforums.com, but am re-posting them here...
One of McClure's quotes that he hammers away at deserves even more hammering:
I would think that the onus is now on the Whittemore Institute to prove beyond all doubt that they are right when the rest of the world cannot reproduce their findings
McClure is not speaking like a scientist here. First, she herself has maintained that the WPI cannot 'prove' anything because their lab and/or samples are contaminated, so how logically can they ever prove anything to her? Second she leaves out the NCI and the Cleveland Clinic, as she always does, who also tested samples for the Science study. If she maintains that they received contaminated samples, then she has the Alter/Lo paper to contend with - yet she also maintains that they had a separate form of mouse contamination. Now two questions arise - how did both labs get MLV contamination, and
why would you assume that it's contamination until proven otherwise? Logic, probability and evidence all argue against contamination; the only argument to the contrary that she raises is the inability of her and a number of other labs to find the virus. The fact that the the two or three labs involved in the CDC study could not find it is at best no more relevant than the NCI and Cleveland Clinic
finding it; all samples in the CDC study came from the CDC. If the sample collection, cohort selection or methodologies were inadequate, then the number of labs involved does not improve the chances of success. Similarly, as cfssufferer pointed out, the number of negative studies is not important; it's the fidelity of replication in science that matters, and McClure knows that (one hopes).
Until someone does a true replication study, no scientist worth her salt would say that the burden of proof lies on the WPI. Nobody has published such a study yet, certainly not McClure. The only researcher undertaking such a study who has reported results, Maureen Hanson, has had positive results, a fact McClure omitted. Her argument about absence of evidence (as she perceives it) supporting the contamination idea is very similar to the psych lobby's contention that unless a disease can be proven to be physical, it is psychosomatic.
She also leaves out the fact that the CDC has tested positive samples from both the WPI and from the FDA and found them all negative. If those samples were positive due to contamination, why did the CDC's assays not pick up the alleged contaminants?
And how she can argue that the mutation of viral sequences in samples from the same patients taken 15 years apart can be explained by contamination is beyond me.