Mikovits interview states the FDA will confirm WPI findings in a Sept publication

[Mark]

I completely agree, WPI's PR skills are a disaster. Dr. Mikovits should not be saying anything about unpublished data, period. This is how you get a bad name in the scientific community and it will certainly not help get funding for future studies form the government or other research organizations.

Well personally I think this whole question of protocol-breaching is going to become very interesting. We see similar patterns in the arguments surrounding Dr Myhill and also the Belgian doctor - these arguments appear to this layman to be disputes over protocol, procedure, "the way things are done". As each feather ruffles, I learn a little more of what goes on behind the scenes, and what people are not allowed to say and do, and I always rather wonder whether the rules of the game themselves deserve some scrutiny.

I have long been aware that science, especially medical science, is slow to deliver, by common agreement. "PR disasters" like these seem to me to throw light onto a world of secrecy in which extreme caution seems to blur into a separation between the "knows" and the "know nots" - with the general public very firmly in the latter camp until the time is right.

We are told that all these leaks and revelations harm the scientific process and slow the process down - somehow, and I'm not sure how. But I'm far more interested in the difference it might have made if Dr Alter's study had been published in however preliminary form back in May when he was confident enough to say "likely" in private conference. Why is it any worse for us to hear a "maybe" too early, than it is for us to hear lots of very-well-reviewed protocol-compliant "definitely no" stories that are completely wrong?

Whoever or whatever the justification for holding back any of the information that is known, I want to register the scientific cost of that delay. What difference would it make to Russian or Chinese or European research and policy in this area to know the preliminary findings? Wouldn't it help accelerate the science if the whole world knew as much as possible, as soon as possible? Wouldn't it change people's decisions over what to research?

So this cost in time to the scientific process, that is lost due to the failure to share and collaborate internationally, is vast. But then so therefore the opportunity is enormous: to modernise and speed up the process of discovery and research - who knows how much more rapidly knowledge might advance in the future?

I realise that this may be "the way things are done" (although the DHHS intervention was definitely NOT normal, as everyone knows), but that is not good enough. It is far too slow and inefficient. When your hopes of a few years of life lived free from torment depend on speed in this process, this sort of wasted time seems far less tolerable. The world just lost 3 months...and counting...

Or is this all about the United States government control of the disease, internationally? Does the US seek a lead in research? Will we now all share knowledge openly around the world? Or seek now primarily to exploit the financial opportunity that sufferers represent? There are always so many choices...

A practicing doctor may not deliver the treatments she personally knows to work if they are not sanctioned and she can be struck off for doing so. A researcher may not reveal what she knows until the proper time, and even revealing that she will soon be revealing something exciting, and saying when, is bad form, apparently.

These things make sense to those close to the heart of the system, I suppose, and are part of a logic, but from a patient perspective it does not make sense and it does not seem caring.

Of course, this is all predicated on the assumption that the doctor is right about the treatments, and the researcher is right about the research. When that proves to be the case, I would imagine that would be a game-changer regarding arguments like this in both cases - more slowly for the doctor than the researcher, and especially slowly for the patient, of course.

Because if announcing your results ahead of time gets you a bad name in the scientific community, making the breakthrough discovery that solves ME does something for your reputation too, in the wider community, although of course some will be more pleased than others...

And if it turned out your treatments were right and helping patients, and everybody else was wrong and harming them, and you just got suspended for helping patients, the mob that suspended you would perhaps have slightly thinner voices as they tried to proclaim "OK: So you were right after all, but that's not the point..."

 

[alex3619]

Hi coxy, I very much doubt can cure us, but if we know the problem - permanent remission of CFS, if we stay on therapy, is a possibility. A retrovirus is incurable with todays technology.

Regarding possible leaks by Dr. Mikovits, please note that she carefully doesn't say what the findings are, only that they have found something. This is a tease, a promise of hope (much welcomed), but not a leak.

Bye, Alex

Does she mean she can correct the immune system for good and we are cured?????????

 

[Mark]

Mikovits did not break the results, others have already done that. There's already been a scientist in the UK saying results will be out in September, and plenty of US scientist have said the study will confirm the finding and more.

It's not new news at all

Nice spot V99, yes of course the September assurance has been around already, and various others have asserted the same. The only part that was news to me was the timescale for the next publication, and I was and am grateful for the information

I await a good justification as to why Dr Mikovits may not say something like this (fearing to hear something about the interests of the journals...).

 

[awol]

Cort and Mark,

You are manufacturing controversy where none exists.

It has been known since the end of May that Alter had positive results that confirm the WPI findings. The only way for this result to have changed in the meantime would have been from political interference.

Dr. Mikovitz did not say anything that was not known and did not reveal the specific results of the study.

This kind of undermining for no apparent reason (personal grudge?) is precisely why I, and several others have chosen not to come here for several months.

 

[Forbin]

In my opinion, it's likely that Dr. Mikovits is very well aware of the issues involved in making a statement to the press at this time. She has probably balanced the pluses against the minuses with regard to issues we may know little about. To borrow a term of art from the CDC, the timing of her statement may well have been "strategic."

 

[taniaaust1]

I seem to remember that last Monday, someone was able to check on a website that lists a brief description of what was expected in the following day's PNAS publication. Has anyone checked this today? Did I miss that?

There is a new illness out now. Its called "XMRV addiction" and thou not usually found within the general communities (very rare), it is found in large numbers in the CFS/ME communities in which it is HIGHLY TRANSMISSIONABLE.

This new illness is capable of altering a patients actions eg frequent internet checking, and also adds to the sleep issues already prevalant in CFS.

There is currently no cure for this newly discovered illness.

 

[redo]

I think the immune system is heavily involved in CFS symptoms, and that there's an infection (or more) which is causing the the immune system to function abnormally.

 

[taniaaust1]

It does look to be a PR disaster as im sure the scienctific community already out to run WPI into the ground, will use this to try to make it look bad. (No one can thou judge her for giving that info out even if she had been the first to leak it.. who knows if Alter knew gave her permission to leak it?? Maybe he wanted it out sooner than later??).

But on the other hand, I personally think that there is HUGE issues with the way this whole system is working. Things ARE NOT the same as they were 10-15 years ago as nowdays info moves like lightening and the old priniciples of withholding info for so long are well and truely outdated due to this. I think the science field needs to change tact and info be allowed to be put out far faster so others can get onto it and follow it all up quicker.

Who does it benefit really to hide and hold on to valid very important science info? in the age where it can be all over the world in moments!!

Science needs to catch up to where things are at!!

 

[RustyJ]

In my opinion, it's likely that Dr. Mikovits is very well aware of the issues involved in making a statement to the press at this time. She has probably balanced the pluses against the minuses with regard to issues we may know little about. To borrow a term of art from the CDC, the timing of her statement may well have been "strategic."

I agree. Since she wasn't divulging anything that wasn't already out there, she has taken the opportunity in front of a wide audience to score a point or two. Masterful. Rather than being a PR disaster, it was good thinking. Will those who just criticised her, be big enough to acknowledge their mistake and commend her actions?

 

[Rivotril]

september is what i heard and said here before...

but no problem for me if it would be released earlier

 

[Mark]

Cort and Mark,

You are manufacturing controversy where none exists.

It has been known since the end of May that Alter had positive results that confirm the WPI findings. The only way for this result to have changed in the meantime would have been from political interference.

Dr. Mikovitz did not say anything that was not known and did not reveal the specific results of the study.

This kind of undermining for no apparent reason (personal grudge?) is precisely why I, and several others have chosen not to come here for several months.

Just to be clear Awol, are you criticising Cort for saying he doesn't know whether she should have broken the story ahead of publication, or me for disagreeing with him and defending her actions in doing so? Both of us for discussing the subject perhaps? Ever get the feeling you just can't win?

Do you similarly condemn everyone on this thread on of both sides of this debate? Or don't you understand that what "has been known since the end of May" has not previously been stated publicly in attributable form?

Your phrase "manufacturing controversy" suggests that, over on the Bad Science board, and in science blogs all over the world, nobody would have noticed this little detail if Cort hadn't mentioned it.

Please let me continue my argument with Cort.

Cort, It could be minimum 3 weeks, technically, to fall on a Tuesday in September, and up to 6 weeks even. So why do you say 2 weeks?

While you are asking why Dr Mikovits couldn't have just waited another 2 weeks, does that constitute a further hint? Since we've been told the paper is in press and ready to go, and are still expecting a chance it will be published today (I thought you suspected so), does Dr Mikovits' statement relate to that decision of publication date, perhaps? Does it mean it has just been knocked back 2 weeks? Is there, perhaps, frustration that it could not be published today - before the WPI Opening?

I find the questioning of the etiquette of Dr Mikovits distasteful when I consider also alongisde it the question: Why don't we have a right to know all this anyway? Especially when scientists at a corporate-sponsored blood-supply conference in Zagreb were considered worthy to receive information back in May that was not meant for our eyes, and when persons unknown have delayed the publication already for 3 months - we are not even told officially who is responsible for that delay, let alone given a reason, we are told literally nothing, no official word about what's going on. In the rights and wrongs of this whole situation, who most deserves to know what?

And while we continue to wait the world gains two more studies discussing the unhelpful personality types of CFS patients, with methodology that characterises us using mysterious magic questionnaires.

You obviously understand how this secrecy business all works and how it's all ethically justified, so I'd love an explanation of how the whole thing works.

 

[thegodofpleasure]

All protocols were negated months ago

Whilst I have been critical of the WPI's poor handling of PR in the past, I see no reason to be critical of Dr Mikovits on this occassion.

The fact that the whole research / publication protocol thing has been smashed to bits by those who sought to interfere with the scientific process (& then treat the Alter/Lo paper differently to the CDC one), IMO nullifies any argument in favour of strict adherence to the "norm" of silence.

Ultimately this issue comes back to whether you believe that Dr. Alter needed to "leak" the results of his work, in order to ensure that it eventually saw the light of day.

TGOP

 

[eric_s]

I completely agree, WPI's PR skills are a disaster. Dr. Mikovits should not be saying anything about unpublished data, period. This is how you get a bad name in the scientific community and it will certainly not help get funding for future studies form the government or other research organizations.

Well, if that really is true (what she said about the Alter paper and the other upcoming papers), and it's looking quite good now, she probably doesn't have to care so much. If she's right about XMRV, she will be BIG. No need to worry about a bad name then, her name will be famous.
I agree she should be careful nevertheless, but i know that i and probably many others are thankful for that information.

 

[guest]

I know this sounds exaggerated but taking into account how science regarding CFS has been treated in the past I'm happy that to some degree the results already leaked. This way they were forced to publish the study no matter what. Maybe if the study had not been leaked it would not have been published at all?!

 

[VillageLife]

Dr Katz mentioned the positive alter paper a lot yesterday in his webinar- he made no secrect of the fact it's positive and it's coming out soon !! He talked very openly.

And can someone PLEASE explain what is ment by the PNAS paper being locked? Is it out or isn't it? (thanks)

 

[Stone]

Originally Posted by Stone
I seem to remember that last Monday, someone was able to check on a website that lists a brief description of what was expected in the following day's PNAS publication. Has anyone checked this today? Did I miss that?

There is a new illness out now. Its called "XMRV addiction" and thou not usually found within the general communities (very rare), it is found in large numbers in the CFS/ME communities in which it is HIGHLY TRANSMISSIONABLE.

This new illness is capable of altering a patients actions eg frequent internet checking, and also adds to the sleep issues already prevalant in CFS.

There is currently no cure for this newly discovered illness.

What's your problem? You sound like Reeves from the CDC. I find your remarks personally offensive as well as slanderous and I demand an apology.

 

[Cort]

Just to be clear Awol, are you criticising Cort for saying he doesn't know whether she should have broken the story ahead of publication, or me for disagreeing with him and defending her actions in doing so? Both of us for discussing the subject perhaps? Ever get the feeling you just can't win?

Do you similarly condemn everyone on this thread on of both sides of this debate? Or don't you understand that what "has been known since the end of May" has not previously been stated publicly in attributable form?

Your phrase "manufacturing controversy" suggests that, over on the Bad Science board, and in science blogs all over the world, nobody would have noticed this little detail if Cort hadn't mentioned it.

Please let me continue my argument with Cort.

Cort, It could be minimum 3 weeks, technically, to fall on a Tuesday in September, and up to 6 weeks even. So why do you say 2 weeks?

While you are asking why Dr Mikovits couldn't have just waited another 2 weeks, does that constitute a further hint? Since we've been told the paper is in press and ready to go, and are still expecting a chance it will be published today (I thought you suspected so), does Dr Mikovits' statement relate to that decision of publication date, perhaps? Does it mean it has just been knocked back 2 weeks? Is there, perhaps, frustration that it could not be published today - before the WPI Opening?

I find the questioning of the etiquette of Dr Mikovits distasteful when I consider also alongisde it the question: Why don't we have a right to know all this anyway? Especially when scientists at a huge corporate-sponsored blood-supply conference in Zagreb were considered worthy to receive information back in May that was not meant for our eyes, and when persons unknown have delayed the publication already for 3 months - we are not even told officially who is responsible for that delay, let alone given a reason, we are told literally nothing, no official word about what's going on. In the rights and wrongs of this whole situation, who most deserves to know what?

And while we continue to wait the world gains two more studies discussing the unhelpful personality types of CFS patients, with methodology that characterises us using mysterious magic questionnaires.

You obviously understand how this secrecy business all works and how it's all ethically justified, so I'd love an explanation of how the whole thing works.

I expected this thread to be about the good news.

We have been drenched in the understanding ever since the Science came out that the findings of a paper are NEVER released before its published and that doing so can imperil the publication of paper. (I can't imagine that would happen here). I didn't make those rules up - I'm simply reporting on them.

Remember the barrage of attacks on the CFIDS Association before the Science paper was released? All they did was say that an important paper on CFS was coming on Friday in Science. They didn't even report what it was on yet they were raked over the coals by the patient community. Now Dr. Mikovits has confirmed the findings of the Alter paper two weeks, she says, before it will be published. How is that not breaking an 'embargo'. She gave us the results. Now we know.

 

[Cort]

Dr Katz mentioned the positive alter paper a lot yesterday in his webinar- he made no secrect of the fact it's positive and it's coming out soon !! He talked very openly.

And can someone PLEASE explain what is ment by the PNAS paper being locked? Is it out or isn't it? (thanks)

If you listen closely you'll hear that he said "I believe" it will be positive. This is what I wrote

while trying to describe the blood community's difficulty in interpreting what were two essentially contradictory sets of data (WPI study and the following 4 studies) he referred to the 'The Elephant in the Room', the Alter study, which he believes will be out imminently (tomorrow?), and which he suspects, but does not know, will be positive.

 

[Cort]

Mikovits did not break the results, others have already done that. There's already been a scientist in the UK saying results will be out in September, and plenty of US scientist have said the study will confirm the finding and more.

It's not new news at all

Really - can you provide links to those stories? I haven't seen plenty of US scientists stating that (to the media).

I can't imagine that Dr. Alter would need to 'leak' a story that has been widely reported to be in press and that it was becoming clearer and clearer was positive.

 

[Cort]

Whilst I have been critical of the WPI's poor handling of PR in the past, I see no reason to be critical of Dr Mikovits on this occassion.

The fact that the whole research / publication protocol thing has been smashed to bits by those who sought to interfere with the scientific process (& then treat the Alter/Lo paper differently to the CDC one), IMO nullifies any argument in favour of strict adherence to the "norm" of silence.

Ultimately this issue comes back to whether you believe that Dr. Alter needed to "leak" the results of his work, in order to ensure that it eventually saw the light of day.

TGOP

Was it actually 'smashed to bits'? It seemed that way at the time but I would say, in retrospect, that it was tweaked. The conspiracy theories regarding the DHHS were, we can now see, clearly wrong. The DHHS pulled back both papers to do further testing - and soon both papers will have been published - with their original findings. I don't see how you can see it any other way ???