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Paolucci et al: 2 out of 12 CFS patients positive for MuLV

Discussion in 'XMRV Research and Replication Studies' started by natasa778, Jul 31, 2012.

  1. JT1024

    JT1024 Senior Member

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    I am sorry if I am repeating myself Firestormm ( and to anyone else reading this thread), please check out the "The MIT Consortium of Adventitious Agent Contamination in Biomanufacturing. I tried to attach a powerpoint but it didn't work.
    Here is a link: http://www.slideshare.net/mewiebe/pda-annual-mtg-2012-caacb-talk

    I have no interest in arguing with anyone. I simply want people to be aware that there are very real risks that the governments and pharmaceutical organizations have recognized. No one wants any type of public response to this very present (IMHO) danger. To understand the risk, you must understand the science. No understanding means you are at risk. Ignorance is not bliss. Ignorance increases you risk.

    Firestormm, you statement " Until such time as one of these family of viruses or any virus is connected to human infection and human disease - all the vaccine manufacturers can do if they think a risk exists is heighten their safety protocols and look for better ways of controlling biohazards." is most timely.

    They ARE trying to make things safer but until the know what they are dealing with, IMHO.. there will be no public warnings of their concerns. It is simply too huge.

    Brain dead here again but that is the norm for me after working 10+ hours. I still work full time in a clinical laboratory just because I can do most of it with minimal brain capacity. Would love to be able to return to my former life.
     
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  2. currer

    currer Senior Member

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    Sorry to hear you are so impeded by your illness, JT1024

    I dont think there will ever be an admission that adventitious agents cause disease If it turns out that they do.

    The financial liability would be too immense. Even though pharm. companies are exempt from liability, as we know they are, I cannot see today's governments being willing to add to their costs in this way.

    So this debate will always be marked by dishonesty and evasion - it is inevitable.
    This is why we ned to watch so closely - because if any facts leak out, it will be inadvertently.
     
    xrayspex likes this.
  3. Firestormm

    Firestormm Guest

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    Morning,

    The notion that vaccination might trigger ME is of course nothing new and neither is the speculation of vaccines and their connection to autism. Despite what Annette tried to do in that video, Mikovits was speculating openly, and revealing something about autism and XMRV that was unpublished and has never been published.

    Now, mesh all that together and consider (not that you have to as I suspect you are more aware than me) what the impact of that pronouncement could/did have on people who thought 'Shit! I always thought my ME/my child's Autism was the result of a vaccination. I must get myself tested for this XMRV. I certainly won't be having any more vaccinations/I certainly won't be allowing my child to undergo vaccination!' And worse. And then when they did receive a 'positive test result'?

    It isn't hard to see why comments like those made by Mikovits annoyed the hell out of me and more so because she never corrected this speculation - it just grew and grew. And now? Alex, you are an adult it's your decision should you opt to not receive any vaccination (not saying that you would/would not). But this whole thing is still 'out there' and there's no evidence to back it up.

    It has long been suspected that vaccination can lead to or exacerbate ME (as you say). This comment just played into that feeling/concern/worry. There was no need for it to have be said, not until a suitable paper could have been produced. Why did she do it at a time when Lombardi et al was being accepted and lauded? The focus ought to have been on that.

    It can be a difficult enough decision to vaccinate yourself or your child without all this fear out there. I don't know what the advice is for people who do have a compromised immune system or an e.g. autoimmune disease - but our condition does not attract such warnings.

    When this has been established beyond doubt then perhaps it will be appropriate to study the effect of a wide range of vaccines and the 'danger' they pose to people with ME and/or Autism. I just think the comments made were inciteful and wholly unnecessary from someone who should have known better.

    Did Mikovits ever look into the effect of vaccination on 'ME compromised immune systems'? No. Sorry but at the time and subsequently - perhaps even more so as she never corrected this speculation - it served only to add more dollops of fear to two already concerned and very isolated patient communities.
     
  4. currer

    currer Senior Member

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    Charles Shepherd of the ME Association in Britain has long taken an interest in vaccines as a trigger for ME and has stated so publicly.

    Is he being irresponsible to be honest about this and to help some of those affected to fight for compensation, as he has done?

    http://www.cfids.org/archives/2001rr/2001-rr1-article03.asp

    (Firestormm, you post a lot of MEA info here so you must already know this)

    When he wrote to the BMJ his letter was ignored. What chance publication, eh?
    I have said before that I suspect this connection (which came to light quite early in the history of our illness) could well be linked to all the problems we have in getting research on ME.

    If you are criticising Dr Mikovits for this you had better add Dr Shepherd in, too.
     
  5. Firestormm

    Firestormm Guest

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    Thanks JT.

    I will try and read through your link now. I did before but didn't get the time.

    Again, this fear that the possible problem is too big, will prove too costly to remedy - might pose a risk to human health - it could all prove groundless BUT as you say they ARE trying to make things safer and they do recognise a problem exists or potential does (in relation to viruses as yet unknown/little known).

    These research studies that we see being published almost weekly now have raised awareness of the potential hazard and there is absolutely no reason to think that investigations will not continue with all due relative haste.

    At the moment this is confined to being a biohazard i.e a potential source of contamination. Do we know enough? No. Of course not. Are we still looking? Yes. Of course we are. IF something is tied to human disease, if one of these MLVs or any other new retrovirus or virus generally is determined to pose a health hazard, why do people think that it wouldn't be afforded a relative degree of response as any other threat to human health?

    You know conspiracy theories aside - money was pumped into looking at the threat posed by XMRV. It WAS XMRV in Lombardi et al. And money HAS been pumped into studies looking at the family of MLV's involving the scientists who had positive results aside from XMRV specifically.

    This HAS been recognised as a potential problem that is not confined to patients presenting the symptoms associated with ME. It has become a much wider issue - and that is largely thanks to the resulting studies that followed the initial revelations in Lombardi and Lo and others.

    If at some time in the future - and I have never though that scientists we simply accepting - e.g. Paprotka is found to not provide a sufficient explanation for XMRV creation, then science will move that hypothesis and evidence forward again.

    Sometimes I think we as patients/laypeople/members of the modern scientific world/whatever expect science to have all the answers all the time and if it doesn't to keep throwing money at the questions until every single one of us has the question answered to our satisfaction.

    Nothing wrong with asking for science to proceed in a direction we think important of course - similarly nothing wrong with demanding that medicine do the same. But there has to be some trust somewhere.

    Will go and read your link now. Thanks for that.
     
  6. Firestormm

    Firestormm Guest

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    I do know Currer. And I was going to refer to this but decided not to (take that how you will) I wanted to stick to the point raised. It's one of the things that he and I don't necessarily see eye-to-eye on. That doesn't mean I'm not aware of the association between vaccination and the onset of symptoms later diagnosed as ME. I just don't think enough evidence has been found to determine/confirm that link. In fact it wasn't all that long ago that he mentioned this to me. I'll have a read of your link though. Thanks for that.
     
  7. currer

    currer Senior Member

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    But you raised the point about Mikovits ! So you need to stick to your own point? So why single out Mikovits?:rolleyes:
    (No, dont answer!)

    But thanks for the information - it is interesting to know that Dr Shepherd still feels the same way.
     
  8. Firestormm

    Firestormm Guest

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    Yes I did. And so far as I am aware - and I'm only 2 paragraphs into your link - Dr Shepherd is still aware that some patients link the onset of their symptoms to a vaccination they received. I'm not sure whether his advice still echoes that expressed in this article from 2001 but I believe there is still a leaflet produced about vaccinations from the MEA. I haven't read it though.

    Edit: Just checked and there are two leaflets available one discussing the pros and cons of Flu vaccinations and the second considers the pros and cons of vaccinations for foreign travel. However, this is probably the one more suited to our conversation:

    'Immunisations and ME/CFS: This letter summarises the evidence both for and against a link between immunisations and ME/CFS. It should be of interest to lawyers researching in this area and healthcare professionals'

    All of them for the bargain price of £1 each.
     
  9. alex3619

    alex3619 Senior Member

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    I regard vaccination as a great public boon. For all its problems, it has saved millions of lives, and improved the quality of life of countless millions. That is not to say it is without problems, and sometimes severe problems. Its not a question of whether or not vaccination is worthwhile. Its a question of under which conditions is it worthwhile, and when should it be avoided, and how should the use of vaccines be modified.

    I do not want to see the return of polio to the general population. It was an extreme public menace. Similarly diseases like measles are greatly underappreciated by the general public. I should know, I had measles encephalitis at age 7. One in four die from it, and two in four develop neurological problems. Vaccines are dangerous. The diseases they save us from are even more dangerous.

    My argument is that we need to understand the issues. We need to have the science to say whether or not a specific individual should be vaccinated. To get there we have to recognize there is a problem - science is not done to answer problems that people do not consider important. That problem is part of why there is so little research into ME.

    I have four major concerns with vaccination. The first is contamination. There is no question that serious contaminants have been found in vaccines. None. There is also no question that contamination is regularly found in vaccines. The drug companies rely on current scientific opinion to say those contaminants do not matter. Mostly that will be correct. There is no way however that they can be certain. The only solution to contamination is to find ways to make vaccines that do not rely so heavily on cell cultures. That would require a major technological advance.

    The second issue is adjuvants. These are vaccine boosters that stimulate the immune system. They make the body pay attention to the vaccine agent. This is deliberately boosting the immune system. Some adjuvants are dangerous and have been abandoned. Most are probably dangerous. The argument is that in such small doses there should be minimal risk. The good news is that technology exists, though still under development, that may make adjuvants obsolete. I hope this happens.

    The third concern is rapid vaccine schedules. An isolated vaccine is not that dangerous, and indeed there are classes of vaccines that have been shown to improve the immune system generally and promote longer life, not just because of what they vaccinate for. (Of course there are classes of vaccines which promote shorter life too.) However these vaccines are not adequately tested for circumstances of where they are supplied to adults or children in rapid succession. Military personel prior to deployment can be vaccinated to a very large number of vaccines in short order. So too can young children - including combination vaccines. This increases risk. It does not make them causal necessarily, its a risk factor. There may be susceptible individuals who cannot handle this.

    The final issue is personalized medicine. How do we know who is a susceptible individual? For the most part we do not. This is an argument for more research into these issues, not so we can abandon vaccines, but so we can properly apply them. To do that we have to acknowledge there is a problem.

    I understand there is a large and widespread panic about vaccines in many cases. We forget about the devastating impact of pandemics, they lie in the past. Modern hygeine has made them much less likely. Unfortunately, thats only a decreased risk. Major pandemics almost certainly still lie in our future. Public vaccination is one measure to prevent this, as is ongoing research into vaccine development. Here in Australia there are cases of young children dying from whooping caugh. They are too young to be vaccinated, and catch it from older children who are not vaccinated.

    One final point. What is the cheapest way to save a life in modern medicine? The flu vaccine, its highly cost effective.

    Bye, Alex
     
  10. barbc56

    barbc56 Senior Member

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    I've been gone for a few days so haven't had time to do anything other than read. There are a few points I would like to qualify but probably won't get to all of them today.
    Barb wrote:
    Bob wrote:​
    Bob, this appears to be a matter of sematics.
    http://www.thefreedictionary.com/stochastic
    http://en.wikipedia.org/wiki/Stochastic_modelling_[/
    (my bold)
    So, yes when the authors of this study use the word stochastic to mean the study might be invalid. However the definition goes further than that as it's the stochastic process which does relies on chance, probability and random events than can make a study valid or invalid.

    Sounds like we are basically saying the same thing.
    Barb C.:>)
     
  11. Bob

    Bob

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    Thanks Barb, I looked up the word myself. :nerd:

    I took it to mean "non-deterministic" (which is the same as 'random'), such that "a stochastic process is one whose behavior is non-deterministic."

    But I've re-read the passage, and I agree that it could be interpreted in more ways than one.

    "It is however intriguing that the only positive results were obtained in these patients. On the other hand, in both cases the positivity could not be confirmed by the amplification of a different virus gene. The proviral DNA amount was very low in our patients, which might explain the stochastic amplification of a single virus gene in each of the two positive patients. Another possibility is that only fragment of virus DNA might be present in biologic samples."

    The context is such that it is referring to the process of PCR amplification, specifically to the finding of only a single gene, for apparently different viruses, in each of the two positive samples. So I interpreted it as meaning that there was no reliability, or pattern, in the results.

    But I suppose it could also be a reference to false positives, although I don't think there was any reference to that in the paper.

    I don't know if PCR has a statistically random element to it, but I didn't see a discussion about statistical unreliability of the PCR results either.

    But, yes, I agree that the results are so minimal that they are inexplicable without further research. Like I said earlier, I don't think it's a helpful study.
     
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  12. JT1024

    JT1024 Senior Member

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    I have not been able to participate for a few days but enjoyed reading posts. Very good discussion points.

    Hope to digest recent posts when my mental faculties are more functional! o_O
     
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  13. barbc56

    barbc56 Senior Member

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    With this illness it sometimes takes two or more people to have the brainpower of one. :)
     
  14. barbc56

    barbc56 Senior Member

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    Feel better soon. I just did the same thing and it really helped with sensory overload. My mental facultties wandered off a long time ago so can certainly relate. I'm sure most of us can. Take care.

    Barb C.:>)
     
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  15. JT1024

    JT1024 Senior Member

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    This thread has gotten a bit off topic (from the Paolucci et al publication to vaccines and ME patients).

    I think the discussion has been great. Hopefully my adding a link for you all to check out will be "ok" since it follows many of the points raised in posts above.

    Found some interesting things from an event held in Barcelona in the spring of 2011. There are slides and abstracts on the site. There is some enlightening information in these slides. The

    Post-licensure Evaluation of Vaccine Safety:
    Current Status and Future Directions


    http://www.iabs.org/index.php/confe...onferences/115-barcelona-slides-and-abstracts

    Session 4
    Safety at the Individual Level
    Chairpersons
    Robert Davis, Kaiser Permanente, Atlanta, USA;
    Neal Halsey, Johns Hopkins Bloomberg School of Public Health, USA

    13:15
    Vaccine safety at the individual level – what have we learned?
    Neal Halsey, John Hopkins Bloomberg School of Public Health, USA : Abstract
    13:35
    Genomics and vaccine safety: Is it possible to pre-identify populations or individuals at risk for adverse events? Example of myocarditis and vaccinia.
    Robert Davis, Kaiser Permanente, Atlanta, USA
    13:55
    Panel Discussion 5:
    Genomics – the road forward.
    Panelists: Neal Halsey (Johns Hopkins Bloomberg School of Public Health, USA); Robert Davis (Kaiser Permanente, Atlanta, USA); Paul-Henri Lambert (University of Geneva, Switzerland)

    Open discussion
    14:40
    Break

    Session 5
    Manufacturing Quality
    Chairpersons
    Tom Verstraeten, GSK Biologicals, Belgium
    Corinne Pierfitte, Sanofi Pasteur, France

    15:00
    The role of safety monitoring to detect manufacturing quality issues.
    Tom Verstraeten, GSK Biologicals, Belgium : Slides Abstract
    15:20
    Panel Discussion 6:
    Experience with using safety monitoring to detect manufacturing quality issues in the developed and developing world.
    Panelists: Tom Verstraeten (GSK Biologicals, Belgium); Corinne Pierfitte (Sanofi Pasteur, France); John Ferguson (Novartis Vaccines and Diagnostics); Xavier Kurz (EMA); William Egan (PharmaNet, USA); Hector Izurieta (FDA, USA)
    15:50
    Discussion
    16:10
    Closing Remarks
    Steve Black, University of Cincinnati, USA


    16:45
    End of the Meeting
     
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  16. currer

    currer Senior Member

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    http://www.iabs.org/index.php/confe...onferences/115-barcelona-slides-and-abstracts
    "Facts, evidence and research findings showing the vaccines to be safe are not enough- vaccine beliefs and behaviours must be shaped.
    This will require a shift in the what, when, how and why of vaccine risk and benefit
    communication content and practice. A change to a “marketing” strategy such as the WHO
    COMBI program that has been applied to disease eradication efforts is suggested"

    Looks to me as if the public are the targets of active propaganda on these matters.
     
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  17. barbc56

    barbc56 Senior Member

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    One person's propoganda is another persons truth.

    Just sayin.
    Barb C.:>)
     
  18. JT1024

    JT1024 Senior Member

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    If you read some of the various abstracts and view the accompanying powerpoints presentations, you will see that the world organizaitons are aware of the problem of "adventitious agents" and they are working to improve safety.

    They are trying to "manage" communications but there is a lot of work to be done. It looks like the World Health Organization (WHO) published Draft #1 of “Guidelines on Assessing Risk When a Potential Adventitious Agent Is Found” on April 11, 2011.

    The work that is being done is fascinating.. so much information, so little time. :(
     
  19. JT1024

    JT1024 Senior Member

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    Interesting stuff!
    Stress Test of Proposed WHO Guidelines for Adventitious Agent Investigations
    Tara Tagmyer, PhD
    Vaccine Manufacturing Sciences and Commercialization
    Merck & Co
    IABS: Adventitious Agents, New Technology and Risk Assessment
    May 19, 2011
    Abstract
    Adventitious agents in vaccine and biological products have been an area
    of concern to regulatory agencies, manufacturers, and public health
    officials since the issue first arose in the early 1900s. While vaccines and
    biologics are manufactured and tested in compliance with regulations,
    quality control tests are broad, non-specific, and may not be capable of
    detecting novel or emerging adventitious agents. Similarly, raw materials
    used to manufacture these products are also tested; however, the
    possibility of adventitious agent contaminations of licensed products has
    been brought to light through the use of new analytical technologies.
    Such non-biased, highly sensitive technologies have been able to detect
    adventitious agent contaminations in licensed products where
    conventional methods have failed to detect them. In response to these
    events, the WHO has developed guidelines for assessing risk when an
    antigen, nucleic acids, or an infectious adventitious agent are found in a
    licensed product. Two case studies are presented to stress test the
    proposed WHO guidelines. The first case study is a brief description of an
    actual event that highlights the strengths of the proposed algorithm. The
    second case study is a hypothetical event that identifies some limitations
    of the proposed algorithm and offers alternative approaches to assessing
    risk using tools and information available. These case studies
    demonstrate that the proposed WHO guidelines work well in an ideal
    situation when sensitive analytical methods are already established.
    Recommendations are offered for assessing risk when the scientific
    knowledge is limited and appropriate analytical methods are not available.
     
  20. barbc56

    barbc56 Senior Member

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    I'm impressed with this.

    Barb C.:>)
     

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