A Game With No Winner

Let the lawyer games begin. My blog “Square One”, of October 1, was unfortunately prophetic. The WPI is in fact using money donated by patients to pay lawyers to sue Dr. Mikovits. One more in a very long line of horrible decisions. I am truly incredulous. This entire fiasco is doing great harm to the patient community, the extent of which is unknowable at this time. The research is destroyed. The notebooks and specimens are potentially compromised.

As I finished that last paragraph, a friend sent me Annette Whittemore’s blog just posted. I really don’t know how she keeps a straight face. She’s suing her chief scientist and the principle investigator on the institute’s grants, after termination without cause, to obtain notebooks and flash drives that Dr. Mikovits apparently does not have, since she was locked out of her lab suddenly and unexpectedly. I would say that as the “the guardian of this property”, Mrs. Whittemore has failed pretty miserably. And now she is using a little of the millions of unaccounted for dollars to sue Dr. Mikovits. I thought I understood the depth of the incompetence, but it just keeps getting worse. She thinks the patient community is going to be OK with this? Business as usual? Wait for the WPI to figure out a cure, without a chief scientist, and oh, please send more money? Who is she kidding? Sorry Annette, now we have to think about a legal defense fund for Judy!

I was going to write some good news, to follow the bad news, but I think I’ll write that when I’m not feeling like I’ve been slimed.

Tonight’s song: Highway To Hell

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373 thoughts on “A Game With No Winner

  1. >Frank Ruscetti has made it clear that this is 1983 and action is needed. The discovery was his also. So when you make up rubbish and attack Mikovits you are also attacking a world renown retrovirologists who has discovered a human retrovirus. If he had changed his mind about his paper and his discovery his name would not still be on his paper. Grow up!

  2. >Why have the WPI or police not traced who Billy is on mecfsforums. He had a gel he should not have access to, posted it on the 4th oct and is clearly hostile to the Mikovits/Ruscetti discovery!

  3. >Billy was not the first person to post the link to the gel. You can believe what you want but Judy was the source of this gel.

  4. >@Jace
    "Gerwyn is a very sick person. He has the same illness that I and most others here have. So saying he should get his arse into a lab is a cruel taunt, asking him to do the impossible.

    Did you know that just standing for any length of time is dangerous for many of us? Do you know how much we have to forgo because of this illness? About the one way we can communicate with the outside world is via the web, writing on our laptops laying on the sofa."
    ROLF

    Do you believe that for one moment that Gerwyn is a sick patient with ME/CFS. With his indepth scientific prattle that spins off more comments, more scientific analysis on more blogs than the entire scientific community combined leads you to believe he is sick?

    It will soon be revealed who is the real voice behind Gerwyn and it is spelled RICO.

  5. >Lol are you two conspiracy theorists done. Anyone with an appropriate educate and interest can do what Gerwyn has been doing and what he will continue to do. Do you know anything about research? Billy was hostile to ZMRVs discovery and would not say who gave him the gel that Science and Coffin saw in 2009. You have no story behind your lies and are only intent to create smoke where there is none. People are not stupid.

  6. >Billy will lead the police to those with the material and who is trying to falsely harm Dr Mikovits.

  7. >If someone said to you find a paper on a human retrovirus where the genetic diversity of all known isolates is less than prostate cancer XMRV, it would take some time, but I could do it. There is nothing special about this. The fact is many people have been looking for such papers to stop the spread of lies about HGRVs and the scientific method.

  8. >anon @ November 18, 2011 9:51 PM

    Whether you like it or not, every word I wrote that you quoted in your post is true. All too true. I see you give us no reference name to connect to you. I on the other hand, am

    Jane Clout screen name jace.

    Internet blogs like this are being flooded by ignorant, arrogant anons, spouting ad hominems in reply to substantive points. Who pays you to do this?

    Are you aware of the realities of ME? I very much doubt it. My head is screaming with many-voiced tinnitus. I feel sick, my muscles ache, my head aches, I am so used to always feeling ill that I have forgotten what it is like to be well. Others cannot swallow, talk, bear light or sound or touch. I am lucky, I only have moderate ME.

    Now we hear Judy has been taken into custody in California, and is to be extradited to Reno. I believe Dr. DeFreitas, the discoverer of a retrovirus in ME patients in the early 1990's, was in a car crash around the time her discovery was being rubbished because the discovery did not suit those in a position of power.

    Judy cannot attend the conference at Mount Sinai tomorrow. The agenda of the control mechanism in action. Stifle communication, stifle research, don't publish what does not agree with your model of ME. Never mind that that model does not work in any shape or form. Tout rubbish papers like the PACE trial.

    Do you think we are blind and stupid?

    My heart goes out to Judy Mikovits. This is history repeating itself. Occupy, anyone?

  9. >From:
    http://www.oslersweb.com/blog.htm?post=824223

    Judy Mikovits has been Arrested in Ventura County on November 18, 2011.
    Judy Anne Mikovits was arrested on Friday in Ventura County, where she lives, and transported to the Ventura County Pre-Trial Detention Facility. When I called that facility this evening, I was told that she was being transported from there to the jail facility on Todd Road in Ventura County. Information about this facility can be accessed on the website of the Ventura County Jail website. http://tiny.cc/c3o5j

    According to the clerk I spoke to, Dr. Mikovits was arrested on an "out of county warrant." The county was Washoe County, he confirmed, when I asked. Washoe County includes Reno and Sparks, NV.

    Currently, the charges against Dr. Mikovits are "being a fugitive from another state."

    Her arraignment will take place at 1:30 p.m. on Tuesday, November 22 in courtroom number thirteen at the courthouse in Ventura, California..

  10. >@Asleep

    1. I have certainly not made a fallacious appeal to history. As I have stated repeatedly, either it is some new, unprecedented methodology or it has been used in the past. If it is some new, unprecedented methodology, you need to clearly establish why science should divert from its normal path, and if you assert that it normal methodology you should substantiate this with references.

    It's not difficult but normal science procedure. In your world, I guess any reference is really just an appeal to history, as everyting has to be established again? I would sure hate to see you bake an apple pie from scratch then…

    If I can get a clear answer from you: Are you of the opinion that what we are discussing is normal scientific methodology, OR are you arguing that the field of virology has just been doing it incorrectly all along?

    Please don't sidestep the question again. Please tell me which option it is. The way to logically prove that I am wrong BTW, is to show that this is a false dilemma by giving another realistic scenario, not by repeating that I am making fallacious appeals to history.

    2. As I have explained, you have selected a few (three) persons that seemingly supported your position, but two of them clearly don't on further investigation. The third (Mikovits) is not highly credentialed and has clearly made logical and methodological errors before…

    3. There is nothing wrong with my analogy, for several reasons:

    a) It does not "harbor the initial assumption that this virus doesn't exist."

    Where did you get that notion? However, in actual real life science, the experiment should be able to provide evidence for the null hypothesis IF IT ACTUALLY WAS WRONG. That is why you should ALWAYS look at your methodology from that perpective.

    b) It does not matter if other researchers exactly followed my protocol. The point is that I could ALWAYS keep asserting that they have just failed to clinically validate their assays to known positives. And precisely because I can always say it, it has no value.

    c) The things you list are not crucial at all. I mreley simplified some things. There are in fact three people that are also finding my virus. Now surely you must agree that other researcher must use our "clinical positives"? Furthermore, I had not told you everyting either about my detection methods: all four perons cabable of finding the virus, use 6 different pink elepehant detection methods. Again, I am sure now you'll agree that other scientists should use our "clinical positives"?

    An analogy is exactly to simplify things. Like I have shown, none of your "crucial elements" really changes the example. It remains stupid to use clinical positives from my pink elephant virus, because it can never validate my finding.

    d) You totally lost me with your last example. Could you rephrase why you think I provided you with a straw man, or else provide another example?

    Don't HGRV proponents see the 0/0 studies as 'failures to detect the virus, instead of evidence of the HGRV hypothesis being wrong'?

  11. >As I said before, you don't mess with the Feds. Intelligent agencies on both sides of the Atlantic have been alerted…Gerwyn. Felony fugitive warrant issued on Mikovits

  12. >@Anonymous November 19, 2011 5:05 AM

    This is not because of the civil case. Even if Judy Mikovits was not allowed to leave the state because of it, there would be no way that a third party's home would get searched by the police (after Mikovits had been arrested).

    This must be a seperate criminal investigation, but of course it is extremely likely that this is still regarding the same subject matter as the civil case (i.e. the WPI's missing notebooks/laptop).

  13. >Since the Whittemores have already had Dr. Mikovits arrested at her home in California, it would seem ridiculous if "intelligent(sic) agencies on both sides of the Atlantic have been alerted…"

    and

    "That civil complaint is scheduled for November 22…" That's interesting. The arraignment in the criminal case which the Whittemores filed against Dr. Mikovits is scheduled in California on the same day, Nov. 22 at 1:30pm. Now isn't that convenient.

    The Whittemores aren't fooling anyone. There is no way they can spin this where they come out looking like anything else but what they are. They have shown very clearly that they don't care one bit about the people who suffer from M.E. except for that one patient who is a member of their family. Their motives are made absolutely clear by this atrocious action.

    Patricia Carter

  14. >RRM the police will want to trace you too. Neither of you have a source for that gel, which would be part if the raw Lombardi data and not the PowerPoint presentation. Both if you have been continually hostile to Mikovits and Ruscettis discovery, so this evidence clearly says who ever has taken that material is not Mikovits. So who are you RRM and who really gave you and Billy that gel to post on the web?

  15. >Err, Patricia, you might just want to remove this from the IMEA site (About the IMEA –> Questions and Answers):

    "We do ask that if people wish to donate to an ME charity, that you consider a donation to the Whittemore Peterson Institute for Neuro Immune Disease."

  16. >@Anon 3:48AM

    You sound like ERV.

    Who has messed with the "Feds"? How would you know anyone has done anything? What power do you think the "Feds" has in another sovereign country and why? Another stirrer without any evidence!

  17. >@Anonymous November 19, 2011 6:24 AM

    Yes, I am sure the police will want to trace me (sigh).

    I actually do have a source for that slide. I thanked him/her here:

    watch?v=Sd6SPwRKxiw

    (You can google it or paste it behind the normal youtube url)

  18. >Neither you or Billy have a source. The police will want to know who gave you both that private gel. "sigh" doesn't cover it, now does it.

  19. >andrea and annette have stated publically that andrea's health is improving from treating XMRV…and there are only 3 drugs that inhibit the virus in vitro: viread, isentress, and azt. so it's not really a big secret…andrea must be on some combination of these 3 drugs, right?

  20. >Jane Clout said, actually (why is the easiest way to post here as an anon?)

    As I understand it, Dr Mikovits has been arrested for supposedly crossing a state line with purloined materials but…

    I. The injunction was taken out a month after the sacking, and a month after the last time that Judy was in the WPI.
    2. Judy was already in Ventura when the injunction was taken out, so even if she had the materials, which Lilly Meehan says is not possible, she cannot have crossed a state line against the terms of the injunction. This whole thing stinks.

  21. >@ Anonymous November 19, 2011 6:41 AM

    Yes, I do have a source that predates my (and Billy's postings). The youtube video was what the original tipster posted with the slide. It's just that I like legal threats so much…

    But you are right, I should really tell where I got that slide from, although I will point out before I do that you should demand proper references from ALL PERSONS that claim things. Saying nonsense like "check HTLV" or "call the BWG" is sadly par for the course for some people that post here…

    Anyway, the source that predates both my and Billy's postings is to be found in comment 296 of ERV's blog on the magic trick (again, not posting the direct link because of the possible spam filter).

  22. >Jace — are you saying you were posting as Kipper7 on Bad Science. Oh my, well you were getting your information straight from Gerwyn then, were you not. You do understand that Gerwyn really has made a lot of erroneous comments regarding XMRV and related testing. Now it all makes sense, why Kipper7 would not post their qualifications and could not really answer any scientific questions without directly regurgitating all the crap posted by Gerwyn elsewhere.
    November 17, 2011 8:25 AM

    I post as Jace or under my real name. I once went to Bad Science, about 18 months ago, when some of them came to PR. I went there to see what the place was about, I didn't like it much, and I've never been there since.

    I have no idea who this fish you mention is. I suggest you work with facts instead of propaganda.

    Funny how it's all about personal attacks with you guys.

  23. > The argument in Paprotka et al. (a study led by Pathak and Coffin) is that the sequence isolated by Silverman, which he claimed came from patient VP-62, is a result of a unique recombination event.  This unique recombination event occurred between a virus, found in many species of mice, and a hitherto undiscovered replication defective erv, when the xenograft which was involved in the creation of the 22Rv1 line was passed through mice.
     
    They claim, but cannot prove that these mice were NU/NU and or Hsd mice, as they contain the viruses or at least the virus fragments they deem to be necessary to further their hypothesis.
     
    They argue that their assays did not amplify XMRV in the early xenografts, but after several passages of the cells through the proposed mice their assays were able to amplify XMRV.  Thus XMRV must have been absent from the early xenografts and created by this unique recombination event.
     
    So we have to judge between two explanations.  One is that the VP-62 sequence was generated by a unique recombination event, or that the PCR assays used lacked the clinical sensitivity needed to detect low copy VP-62 sequences in the early xenografts.
     
    Given that a unique event is so very unlikely they must provide very strong evidence that VP-62 equences were indeed absent from the early xenografts and that their apparent absence was not caused by the failure of their PCR assays.  Absence of evidence is not evidence of absence.
     
    If one focuses on the initial quantitative PCR assay using one envelope primer it becomes clear that there is no evidence provided regarding the copy number of VP-62 sequences per 100 cells in the NU/NU or Hsd mice, later xenografts or early xenografts.  This is because the PCR amplified what were known to be VP-62 sequences from the DNA taken from 22Rv1 cell line and the CWR-R1 cell line.  The problem here is that the copy number of VP-62 in these cells is huge, being 2000 copies per 100 cells and 3000 copies per 100 cells respectively.  We do know that this assay could detect ERV sequences in the mice and the early xenografts, but we don’t know what the copy number of ERV sequences is compared to the copy numbers of VP-62. Thus it is quite possible for VP-62 sequences to be present but undetectable, due to a lower copy number for example.  There are other more complex reasons.  In any event absence of evidence is not evidence of absence.  We also have the problem that this assay with the env primer was not used to screen other species of lab mice or wild derived mice.  Had this assay being able to detect either XMRV or ERV sequences in these mice the paper would have collapsed.  Certain vested interests have argued that it would be silly to use this assay with this primer to screen the other mice because the primer could amplify both VP-62 and ERV sequences.  In that case why use that primer to screen NU/NU and Hsd mice, and indeed why use that primer at all. I wonder what the defense is for not using this primer and assay to any screen wild mice.  Wild derived mice are not wild mice.

    Part 2 below

  24. >There is no evidence that this assay can amplify XMRV specific env sequences other than in the DNA taken from 22Rv1 and CWR-R1 cells.  There is no evidence that this assay with this primer could detect VP-62 sequences in the DNA extracted from lab mice, the early xenografts or the later xenografts.  The later xenografts were not screened using this assay.  In fact figure S3 in the SOM (Supporting Online Material) shows that provided this primer was used at all to screen the later xenografts using the second single round PCR, then that PCR assay could not amplify any product.  As this primer was used to screen the early xenografts with the second PCR assay (Figure S3), not to use it to screen the later xenografts would be a serious departure from the scientific method.
     
    Next we examine the second PCR single round assay with a gag primer, which is only capable of detecting VP-62 gag sequences. Figure 2D and 2E suggest that this assay, with this primer, was used to screen the early xenografts.  This is however in direct conflict with the text, which states that all the primers used with the single round assay were capable of amplifying both VP-62 and ERV sequences.  This is prima facie evidence of misfeasance and at the very least should be investigated.  In any event, it seriously weakens if not invalidated their claim that gag sequences were not present in the early xenografts.  Indeed we once again have the scenario that there is no evidence that this single round assay can detect VP-62 gag sequences in anything other than the DNA taken from the 22Rv1 or CWR-R1 cell line either.  So they cannot provide evidence that their assay could detect VP-62 GAG sequences in mice or later xenografts let alone the early xenografts.

    Thus I will leave it to those without vested interests to consider whether these authors have provided convincing evidence that VP-62 sequences are absent from the early xenografts, bearing in mind that absence of evidence is not evidence of absence and that the alternative explanation is a unique recombination event, which cannot have happened in the past and its future occurrence is a virtual impossibility.
     
    Finally the paper does not fulfill the minimum requirements of surviving a peer review process.  There is not enough evidence to enable the scientific merit of the study to be judged or enough data in the methodology section to enable replication.  The claim that it is custom and practice among a certain group of retrovirologists not to include such details unless they deem it necessary merely means that none of their studies should have passed the Science peer review process or indeed any rigorous peer review process.  Contrary to statements made by certain vested interests the Science magazine is not published merely for the perusal of certain retrovirologists but also other scientists from different disciplines.  I would remind everyone what the requirements of science are:

    Data and materials availability
    All data necessary to understand, assess, and extend the conclusions of the manuscript must be available to any reader of Science.

    Paprotka et al., ‘Recombinant Origin of the Retrovirus XMRV’ does not meet the requirements as specified by Science.

  25. >No crime has to have been committed for Mikovits to be arrested and of course she is innocent until. Anyone claiming different clearly wants to live in an oppressive state and stop HGRV research.

    Stop the Lipkin study! It is unscientific and not needed.

  26. >What planet are you living on ? You want to stop a piece of research by one of the most respected scientists on the planet ? I am a CFS patient. I believe in all scientists carrying out their research unhindered. ALL scientists. Even Simon Wessely. Yes, indeed. You can rubbish his published work 'til the end of time ( and I would gladly join in ) but you NEVER stop the science from taking place.
    Of course, there are lots of examples from history where scientists were indeed told what and what not to study. Do you really want to keep that company ?
    Why don't you shut up and leave researchers – particularly world-class ones who I am extremely grateful have taken an interest in a much-maligned field – to research FREELY.
    You are a dangerous idiot. And that's not a personal attack. Based on your moronic post that is fair comment.

  27. >So only research YOU think is worthwhile should take place. All science should take place FREELY. You can criticise it all you want AFTER is gets published ( if it gets published ) but you don't stop any research. Historically we have examples of people who decided which research should and shouldn't take place : you're in pleasant company, aren't you? I am delighted one of the best researchers on the planet has taken an interest in our much-maligned illness. You are a dangerous idiot. That's not a personal attack but fair comment based on your moronic post. Get a grip on your ego.

  28. >The only studies that can have any influence over the results of Lombardi or Lo et al are those that use clinically validated assays. Any other paper means nothing as there is no evidence the assays can detect positives. The dangerous idiots are people like yourself anon 10:49. There is no way you would ever be allowed or taken blood from a person screened for HIV with an assay that is not clinically validated.

  29. >All science should take place FREELY without single papers using invalidated assays being used to silence, stop or hinder further scientific research. Everyone knows it is an outrage to have set up a study as definitive.

  30. >A while back I posted asking for someone to list what robust scientific results Mikovits has achieved in the last two years? Can someone please do that (and don't just repeat what you think other researchers have done wrong – that's a redundant argument).

    Cos a whole lot of the Mikovits faith is based on the assumption that she has done good research that will help patients. As far as I can see, she's had one major publication on XMRV that is now partially retracted and possibly will be fully retracted; has had to admit to contamination in her lab after being foolishly hostile about the idea to colleagues, is under investigation by a leading scientific journal for possible research misconduct; has posted sequences to Genbank that turned out to be not signficiant and has failed to post the promised "exciting" ones.

    What am I missing?

    (I am not dicounting the idea of a retrovirus. And I know that scientific discoveries sometimes follow convoluted paths where things don't pan out, so you try different angles, and then maybe, you have some evidence. Other researchers try too, and then maybe you have enough independant results for the evidence to look robust. But I don't see Mikovits as having got to the part of having valid looking evidence yet, and we really, really do *not* have a body of robust independant evidence supporting her claims.

  31. >What robust research have people like Coffin, Stoye, Towers, McClure etc produced in the last 2 years? Clinically invalidated assays! When was the last time any of them discovered a human retrovirus?

    Mikovits has published Lombardi et al. (2011) and Lonbardi et al. (2010) since Lombardi et al.

    The evidence is in those papers I the form of a human immune response that can only be to an MLV virus, EM of the budding virus maturing. Neither if those can be contamination. A second positive study from Lo et al find polytropic gag sequences. There is more, but can you not understand that none of that evidence has been challenged as they didn't use clinically validated assays in the negative papers. All if that is robust evidence.

  32. >"What robust research have people like Coffin, Stoye, Towers, McClure etc produced in the last 2 years? Clinically invalidated assays!"

    And how do we know those assays are invalidated? Because a few anonymous people with an elementary school level understanding of science have said so over and over and over again on message boards.

  33. >The assays in the negative papers are clinically unvalidated. The evidence is in the papers themselves. Have you ever read them?

  34. >@anon 10:49 am
    "Mrs Whittemore was obviously very sincere in wishing Judy all the best."

    Here is my summary of the events of the past few weeks. You decide the level of good wishes:
    Dr. Peterson leaves WPI for unknown reasons.
    Dr. Deckoff-Jones is fired as overseer of the doctors listed to practice there.
    All the doctors on the new staff list at that time disappear.
    Dr. Mikovits is invited to participate in a panel on ME/CFS with highly respected ME/CFS doctors such as Dr. Enlander and others.
    Dr. Mikovits is fired for disrespecting Annette, or so the rumor goes.
    WPI owns the research Mikovits has done, but Mikovits protests that she needs to hold the work details that were funded by the NIH so that she can continue the work THEY ARE PAYING HER TO DO.
    WPI files a lawsuit against Mikovits accusing her of taking research that she does not have rights to.
    M. leaves for California and is called on the phone and told by Annette Whittemore that she is fired and cannot have the materials. M. goes to her house and then on to California without her materials.
    M. is then arrested and her home and a friend's home up the street is searched. [I assume this is for the research materials.] M is charged with fleeing the state where she has been accused of stealing the patented research materials.
    M. is now in the Ventura county jail without bail until her hearing on Tues, the 22nd of November.

    This is my limited understanding of Annette Whittemore's respect for Dr. Judy Mikovits. Happy Thanksgiving, one and all. [Sarcasm here in case it is not obvious. Perhaps ME/CFS patients living in the Reno area would like to occupy the front door of WPI.]

  35. >One more detail – the research files are missing, but no one has determined who took them or where they are at this time.

  36. >"The assays in the negative papers are clinically unvalidated."

    Of course they are, because they are in negative papers. And if there is ever another positive paper, the assays used in it will automatically be considered clinically validated. Yes, that is crystal clear, no worries.

  37. >Paula,

    That's a nice piece based on "rumour" and material from various forums, it would appear. Meanwhile, the actual facts are that a certain person has been arrested and is under investigation for research misconduct.
    Perhaps it would be a good idea to wait and see what actual evidence there is, or is not. Unfortunately, supporters of Dr M and XMRV seem to have a really difficult time with actual "evidence" don't they ?

  38. >kathy d, i did see that the Enlander seminar will be recorded and made available. Ive lost the details, but I did read that today.

  39. >Hey! There's this thing I've found – it's usually only found in elephants, but I've found it in sick people.

    What do you mean you can't find it in the sick people – you're not looking right. Look over there, there it is – what! still can't see it – you're still not looking right. What do you mean, none of you can see it? Sure it exists, you're still not looking right. Here look, we'll all do it together, and I'll do it too, and .. oh… you can find it in the elephants, but not in the sick people, and I can't find it in the elephants, or the sick people, but I found it somewhere we all agreed it wasn't before we started……

    Oh – well that just shows that none of us know how to look properly (including me, who said I'd found it cos I knew how to look).

    How's your circular logic Gerwyn?

  40. >An assay is only clinically validated if if is validated against a clinical sample. It is mpossible to recreate with a synthetic virus the conditions needed for an integrated wild type virus. It is illegal to state a person is not infected with HIV with an assay that is not clinically validated. As Singh, Mikovits and Racaniello have stated. If a clinically validated assay is them used and finds nothing that assay will still be clinically validated. Bit without that data, the assay cannot be said to work and a person cannot be said to not be infected. The assays in Lombardi et al were clinically validated.

  41. >Neither Frank Ruscetti or Judy Mikovits are under investigation for research. The gel issue was settled as it was seen by Science and the reviewer coffin pre publication and they requested the label change.

    The civil case and the issue of missing materials are also not known to be related and do not involve the person who made all the WB gels. Mikovits did not perform that section of the study. The materials clearly are in the hands of people hostile to the HGRV discovery, as both RRM and Billy cannot state where they got those gels.

  42. >Yo Dawg, I herd you like clinically validated samples so we put a clinically validated sample in yo validation study so you can clinically validate while you validate.

  43. >"An assay is only clinically validated if if is validated against a clinical sample." and "The assays in Lombardi et al were clinically validated."

    Once again, how can the Lombardi assay be clinically validated if the clinical samples used to "validate" it are not 100% guaranteed certain to be positive to begin with?

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