Light blue touch paper and stand back…we’re in for a kicking

“Drug companies have long been castigated by lawmakers and advocacy groups for a lack of openness on research, and the investigation shows just how far individual firms have gone to skirt the disclosure law. But while the industry generally performed poorly, major medical schools, teaching hospitals, and nonprofit groups did worse overall — many of them far worse.”

The federal government has the power to impose fines on institutions that fail to disclose trial results, or suspend their research funding. It could have collected a whopping $25 billion from drug companies alone in the past seven years. But it has not levied a single fine.

It is claimed that “Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.

The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for diseases.

The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008.

If interested read this post (CLICK HERE).

So take a deep breathe before you start to rant at me, because we are guilty of not writing up clinical studies in a timely fashion, just as some of our experimental stuff has not yet seen the light of day.

So I am not going to comment on this to save words like “calling the kettle black” come out…as you will say what has happened to the Charcot project……..more like the Chilcott Project and all air and nothing to be seen. 

You are not quite correct on this as the Investigator meeting was only this month and not years ago as you think, but it is true results take time to surface and this is particularly the case with negative results. 

Journals are not interested in negative studies and companies are not interested in publishing negative studies as it is not part of the marketing strategy. Sometimes even positive ones do not surface for example the cladribine studies reported in AAN in 2013 have not surfaced or data from 2009 reported at ECTRIMS etc, etc, etc.

Was it that the trial failed because the treatment was no good or was it because you were filled with hot air when you said you would volunteer for the study when you actually won’t so the study never got off the ground. Or was it that we over estimated interest or was it the study was registered but never funded and so it never started.

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  • On a related note, I've found the Aussie Nurofen debacle illuminating,amusing and depressing at the same time. Pharma says its tired of everyone giving them a kicking but keep giving everyone so much ammunition.

  • "…or was it because you were filled with hot air when you said you would volunteer for the study when you actually won't so the study never got off the ground."

    At my neurologists office they post openings for clinical trials and discuss this with the patients to get commitment. Maybe this is a better way that having a pole posted on a blog where anonymous patients can vote.

  • As an Aussie who has also watched the Nurofen debacle hit the headlines Yes – the pharma company has indeed been playing some naughty tricks! However, the main question that comes into my mind is "Can't these people who have been sucked in by the flashy packaging read?" It's very clear on the front of all of the different packets that the same active ingredient is present in exactly the same quantity in all of the products, regardless of the labelling claiming that it is designed for a specific type of pain.
    Where I live all ibuprofen is kept away from customer access in pharmacies, so you have to ask the staff for it, and every time you buy some they remind you that it must be taken with food to reduce the risks of stomach bleeding. While on Rebif I got a bit sick of being given this advice constantly, even though I understand why they do it. What they don't tell you about is that constant use of ibuprofen can cause a folate deficiency – probably because there is such a low level of awareness of this potential problem.

  • In addition to commercial interests, the difficulty with publishing negative results is very real. Journals are not interested, so getting negative results out takes as much (if not more) time than publishing something that at least looks positive, and then whatever is published ends up in obscure journals. Researcher's time is limited, and the choice of the manuscript to work on would likely be made in favor of positive results.

    • Indeed. But all this runs deeper than that. Prof G. said it very very eloquently (not so much LOL) at his NMSS visit yesterday. "These systems are Victorian". Reminded me ever so much of the one Star Trek movie where Doc McCoy has to deal with the 20th century med system to help Chekov.

      He hit a nail on the head with his thumb.

      People that speak out given the chance to do so are the people who change the course of things as history has shown again and again. Sometimes positively, sometimes not so much. But it takes risks to make gains.

      These systems should ALL work more uniformly and have restructuring. Said restructuring towards globalization since that is where we are all headed like it or not.

      The better "systems" are able to be prepared to molt together the less anarchy will occur when they are .vs. atom smashing.

      I have no idea how much thought Prof G and Barts put into some of the thoughts regarding group concepts, its smart, its doable, it'd have a significant impact and can begin quite fast. No having to wait for an "XY Doohickey to be invented". Atop it could also lay a foundation of support of MSer to MSer's be built, highly applicable to virtually all forms of chronic disease and even many diseases not chronic in nature.

      Someone give Captain Picard Oz's wand so he can wave it and say "Make it so".

  • I'm afraid team g definitely over hypes their studies. Look at the hoopla over Charcot- bbc, black swan. Hope you have learnt your lesson.

  • "Journals are not interested in negative studies …"

    Historically yes, but now the tide is turning. Journals are under more and more pressure to publish so-called 'negative' studies, due to the exponential publication bias that now exists. It is up to researchers (and their funders) to liaise with editors (not just of journals with high impact factor!), to convince them that ALL results of rigourously designed & executed studies SHOULD be in the public domain, if only to prevent futile duplication by other labs.
    See the Lancet series on reducing waste in research:

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