David Tuller: 'Trial by error continued: the real data'

[Kati]

http://www.virology.ws/2016/09/22/trial-by-error-continued-the-real-data/

This last piece is juicy, well written and stepping up the tone as well which is justified. I am adding a screen shot of a paragraph that I used for Twitter. Well done, David and thank you!

 

[Kyla]

http://www.virology.ws/2016/09/22/trial-by-error-continued-the-real-data/


excerpt:

Trial By Error, Continued: The Real Data
22 SEPTEMBER 2016
by David Tuller, DrPH

David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley.

‘The PACE trial is a fraud.’ Ever since Virology Blog posted my 14,000-word investigation of the PACE trial last October, I’ve wanted to write that sentence. (I should point out that Dr. Racaniello has already called the PACE trial a “sham,” and I’ve already referred to it as “doggie-poo.” I’m not sure that “fraud” is any worse. Whatever word you use, the trial stinks.)

Let me be clear: I don’t mean “fraud” in the legal sense—I’m not a lawyer–but in the sense that it’s a deceptive and morally bankrupt piece of research. The investigators made dramatic changes from the methodology they outlined in their protocol, which allowed them to report purported “results” that were much, much better than those they would have been able to claim under their originally planned methods. Then they reported only the better-looking “results,” with no sensitivity analyses to analyze the impact of the changes—the standard statistical approach in such circumstances...

read the rest here:
http://www.virology.ws/2016/09/22/trial-by-error-continued-the-real-data/

 

[Tom Kindlon]

https://twitter.com/i/web/status/779094560857292804

 

[AndyPR]

Dr. White, his colleagues, and their defenders don’t yet seem to grasp that the intellectual construct they invented and came to believe in—the PACE paradigm or the PACE enterprise or the PACE cult, have your pick—is in a state of collapse. They are used to saying whatever they want about patients—Internet Abuse! Knife-wielding! Death threats!!–and having it be believed. In responding to legitimate concerns and questions, they have covered up their abuse of the scientific process by providing non-answers, evasions and misrepresentations—the academic publishing equivalent of “the dog ate my homework.” Amazingly, journal editors, health officials, reporters and others have accepted these non-responsive responses as reasonable and sufficient. I do not.

Jeez David, don't beat about the bush, say what you mean..

 

[Sidereal]

Horton's behaviour is unacceptable.

 

[*GG*]

https://twitter.com/i/web/status/779094560857292804

Should really be a LOVE or Super Like function for posts like this!

GG

 

[CFS_for_19_years]

Tuller:

Now their work is finally being scrutinized the way it should have been by peer reviewers before this damaging research was ever published in the first place. The fallout is not going to be pretty. If nothing else, they have provided a great gift to academia with their $8 million disaster—for years to come, graduate students in the U.S., the U.K. and elsewhere will be dissecting PACE as a classic case study of bad research and mass delusion.

In the comments section - Chris: (bolding mine)

As a currently active clinical trials statistician, working frequently with all phases of clinical trial, both blinded or unblinded, and especially prospectively planning and analyzing double blind randomized clinical trials in the pharmaceutical industry that will be used for approval and marketing authorization by regulatory agencies (FDA, EMA etc. ), it is mind boggling that the PACE investigators made changes to the planned analysis in an open label study.

We view as potentially "tainting" a -blinded- study to change a primary endpoint or the planned analysis. By the ICH "E3" (international conference on harmonization) guidelines we are required to clearly state any changes and the reasons why any changes were made to the planned analysis. I have on one occasion had to make the argument to a narrow minded client that ---- the definition and preparation of a valid statistical analysis was implicit in the informed consent and in submissions to the IRB and must occur well in advance of database lock and regardless whether data was blinded or not and particulary before viewing any data (blinded or not). Furthermore there is an ethical obligation to the patients to prepare the most sound statistical analysis possible - failing to do so it is then unethical to ask patients to participate in the trial.[.....]

 

[alex3619]

Horton's behaviour is unacceptable.

Its all unacceptable.

Science has taken some very wrong turns in the last few decades, but perhaps the most insidious and dangerous wrong turn is how so many in media, bureaucracy and the medical community completely fail to grasp the obvious problems.

The question that inevitably arises is this: if they fail to grasp the obvious, how can we trust them in any other matter? They have diminished credibility.

There are lots of extenuating circumstances, this does not lead to blame for the media, bureaucracy or medical community, but it does show a failure in responsibility.

 

[Kati]

Horton's reaction makes me curious. What's his story? Did he accept any kind of bribe to fast track publishing? What's for him to lose (other than his reputation)? Who does he get orders from? How big is the network of lies and vested interests (essentially, a cartel)?

It sounds like crazy, I must admit, but then, the british psych lobby is planning to apply the PACE trial to children now. As crazy as it is, and how did this pass ethics board? There must be forces out there that perpetuates these things from happening. Who is at the top of the cartel? How far does it go?

 

[Esther12]

imo Horton genuinely thought he was bravely standing up for rigorous science against a small band of militant anti-science activists. He was too stupid to spot the problems with PACE, and possibly still doesn't understand them now. He was so supportive of PACE and condemning of patients who criticised it that he now cannot acknowledge the problems that everyone else sees.

I do think that there's a side story about the way Horton placed himself in a position where he could no longer acknowledge how flawed PACE was. This seems like a clearly bad thing for a journal editor to do.

 

[Seven7]

Finally! Somebody with the pelotas in the right place to call it fraud!!!!!

 

[Kati]

This:

https://twitter.com/i/web/status/779135486896005120

 

[mfairma]

The question that inevitably arises is this: if they fail to grasp the obvious, how can we trust them in any other matter? They have diminished credibility.

There are lots of extenuating circumstances, this does not lead to blame for the media, bureaucracy or medical community, but it does show a failure in responsibility.

I was trying to make this point with a friend recently, but I couldn't convince him. Edge cases often demonstrate the functioning of the system. When the whole system -- medicine, media, and politics -- can fail so completely for so many years, as it has in this disease, how can you have faith in the certainty of the conclusions offered in other spaces? You can't, at least not absolutely so.

Certainly, the imperatives of the system drive behaviors that are detrimental to the whole and it is hard to hold individuals accountable for behaviors driven by systemic factors, but, nevertheless, I don't think we can hold individuals blameless for complicity in promoting certainty despite low knowledge, even if the system holds up that behavior as ideal. The pressures of journalism may militate toward lightly researched articles and shallowly informed opinions and the pressures of medicine may do the same, but that, to me, doesn't excuse the certainty with which judgments are rendered.

 

[Sean]

Mr Horton may have no plans to correct his errors, but others do.

 

[Sean]

Its all unacceptable.

Science has taken some very wrong turns in the last few decades, but perhaps the most insidious and dangerous wrong turn is how so many in media, bureaucracy and the medical community completely fail to grasp the obvious problems.

Cannot be emphasised enough.

The PACE team, and their like-minded colleagues, could not have got away with all this if they had not had high level support and protection from the political and economic elite, and their useful idiots in the mainstream corporatist media.

The real reason PACE is being so irrationally, relentlessly, and at times viciously defended, is that if it goes down so do a whole lot of other people and projects.

This goes way past just little old PACE and psycho-social medicine. Waaaaaaaaaaaaay past.

 

[alex3619]

This goes way past just little old PACE and psycho-social medicine. Waaaaaaaaaaaaay past.

I suspect so, particularly since much of the biopsychosocial agenda has close ties to political agendas and private vested interests (mainly insurance).

I have said before that I feel a need for popcorn as this unfolds. I have issues with corn, but the way this is unfolding I would need to live next to a popcorn factory to supply me with enough popcorn.

We have been waiting for this for decades. The PACE disgrace is just another in a long line of problem research, but its also the biggest and most influential. They should have learned the lesson with the FINE trial, but maybe they did, and that is why things went even more wrong with PACE.

 

[Esther12]

Also: another interesting peice - great work David Tuller!

I've become so used to his work, and more recently the work of others, that I've almost stopped being grateful for it. I just take for granted that he is going to be slogging away, fighting to help improve things for us. I need to regain some perspective and start praising God for David Tuller.

 

[leela]

Now it’s clear: The PACE authors themselves are the anti-science faction.

When I read this sentence I felt like Maria twirling around in the mountains singing "The Hiiiiillllls are Aliiiive With the Sound of Muuuusic."

Seriously, Tuller ought to have been the one who was knighted.

 

[Large Donner]

He was too stupid to spot the problems with PACE, and possibly still doesn't understand them now.

That's about as far as one can take stupid. Is there an infinite amount of stupid and can you double it. Can the universe even accommodate that amount of stupid? It must be an ever expanding amount of stupid the kind of stupid that runs out of dark matter to expand into in an infinite amount of stupid.

The question is, if he really is that "stupid" who employed him and why?

I think the problem for the Lancet is that they are afraid of being called an infinite amount of monkeys.

 

[Glycon]

When you have dug yourself a grave so deep that your only hope is to play dumb and hope everyone ignores you as you frantically try to dig your way to China: