Archive for the ‘Research’ Category

Another case of promoting a drug with “incorrect reporting and distorted data”

September 17, 2015

There is a Catch 22 situation here.

Clinical trials for new drugs are all funded – of necessity – by the pharmaceutical companies. It is only to be expected that negative results are downplayed and positive results are highlighted. Positive results get published. Negative results for drugs not yet approved are rarely published. Those conducting clinical trials are looking to enhance their lists of publications. Furthermore there is an incentive to invent “medical conditions” which can be “treated” by otherwise useless – or even damaging – compounds. My perception is that the pharmaceutical companies sometimes discover compounds unintentionally or by accident or as a compound which fails its originally intended purpose. Then – by defining (or inventing) new medical disabilities – they try and find a use for these compounds.

So how many of the new, psychiatric drugs are really of no benefit? And how many of the supposed “illnesses” – which can only be diagnosed by subjective methods – and which these new drugs are supposed to to treat – are really medical conditions?

A University of Adelaide led study has found that a psychiatric drug – paroxetine – which was claimed to be a safe and effective treatment for depression in adolescents is actually ineffective and associated with serious side effects is published today in the BMJ.

Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ, 2015 DOI: 10.1136/bmj.h4320

there is also an editorial in the BMJ:

No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

UofAdelaide press releaseProfessor Jon Jureidini, from the University of Adelaide’s newly created Critical and Ethical Mental Health Research Group (CEMH) at the Robinson Research Institute, led a team of international researchers who re-examined Study 329, a randomised controlled trial which evaluated the efficacy and safety of paroxetine (Aropax, Paxil, Seroxat) compared with a placebo for adolescents diagnosed with major depression.

Study 329, which was funded by SmithKline Beecham (now GlaxoSmithKline), was reported in 2001 as having found that paroxetine was effective and safe for depression in adolescents. However, Professor Jureidini’s reanalysis showed no advantages associated with taking paroxetine and demonstrated worrying adverse effects.

“Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report,” says Professor Jureidini. “It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviours compared to only one person in the group of patients who took the placebo,” he says. “Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo.”  ……

……. “Study 329 was one of the trials identified as in need of restoration, and because the original funder was not interested in revisiting the trial, our research group took on the task. 
“Our reanalysis of Study 329 came to very different conclusions to those in the original paper,” he says. “We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data.”

If all doctors treating patients were truly independent the system would be self-correcting. Overhyped and unnecessary drugs would wither away. But many doctors have a vested interest in the continued use of the drugs they prescribe. (And note that even some members of the WHO panels who recommend mass vaccination programs have been found to have vested interests).

As the editorial in the BMJ writes:

But in the case of Study 329 no epistemological acrobatics would seem able to reconcile the differences between the 2001 JAACAP paper and the RIAT republication. They cannot both be right. …

Such stark differences between the original paper and the rewrite are bound to put particular pressure on Andrés Martin, Yale University professor and current editor in chief of JAACAP. Martin has been under pressure to retract the paper for years, including from within his own society. Last October, Martin was compelled to address the academy’s assembly about Study 329. According to the minutes, members heard how Martin had investigated the matter thoroughly by consultation with the authors, the Committee on Publication Ethics (COPE), clinical experts, “a whole range of attorneys, and more.” Martin’s assessment, completed in July 2010, concluded that no further action was necessary. A follow-up inquiry, again by Martin, in 2012, after GSK was fined $3bn, similarly concluded “no basis found for editorial action against the article.” ……

It has proved no easier to get the professional society to talk. Several of the authors of the JAACAP paper are members of the American Academy of Child and Adolescent Psychiatry (AACAP). The BMJ sent four requests for comment to the academy’s president, Paramjit Joshi, and past president Martin Drell, but received no response.

Scientists behaving badly and psychiatrists behaving very badly. A can of worms no doubt.

The data, all the data and nothing but the data

January 5, 2012

(Reuters)Unreported data from early trials of experimental medicines in humans can result in harm to future patients and needless costs for health systems, according to scientists writing in the British Medical Journal on Wednesday.

The role of statistics in research leads to obvious risks for the drawing of conclusions about causal relationships between parameters without actually increasing the understanding about the underlying mechanisms. In pharmaceutical and health research such conclusions provide enormous financial benefits for the researchers and their sponsors – and not always in the interests of the patients involved.


Misuse of peer review by UK Research Councils leads to mediocrity

September 14, 2011

The 7 UK Research Councils are publicly-funded agencies responsible for the funding of most research in the UK. They have often been criticised for being much too “establishment” driven such that any line of research considered heretical is strangled of any funding. Donald W. Braben is honorary professor in the department of earth sciences, University College London and known for his support for academic freedom and “blue-skies” research. In an article in The Times Higher Education Supplement,  he comes down hard against the research councils and their use of “peer review”. He argues that they inherently discourage  any “pioneering” research and drive towards mediocrity.

Until about 1970, academic researchers were usually given modest funds to use as they pleased. This apparent profligacy led to a prodigious harvest of unpredicted discoveries and huge stimulants to economic growth. ……. 

It is said that peer review is like democracy: it’s not the best but it’s the best we know. But science is not democratic. One doubtful scientist can be right while 100 convinced colleagues can be wrong. Indeed, the physicist Richard Feynman once defined science as “the belief in the ignorance of experts”. Specifically, peer review of grant applications, or peer “preview”, is inimical to radically new ideas. Today, however, the all-powerful peer-preview bureaucracy is the determinant of excellence. It is taboo even to criticise it. So the natural inclination to oppose major challenges to the status quo has become institutionalised. For radical research, one can argue that “the best we know” has become the worst. 

“Independent expert peer review” is contradictory. One submits a proposal and the councils ask experts to assess it. But these experts are likely to include proposers’ closest competitors, even if they are selected internationally, because science is global – and real pioneers have no peers, of course. How then can the councils ensure that reviews are independent? To make matters worse, these experts can pass judgement anonymously: applicants don’t know who put the boot in.

I suggest that the misuse of peer review is at the heart of the research councils’ problems. Before about 1970, they largely restricted its use to the assessment of applications for large grants or expensive equipment. Scientific leaders protected the seed corn, ensuring that young scientists could launch radical challenges if they were sufficiently inspired, dedicated and determined. Today, the experts whose ignorance they would challenge might also influence their chances of funding. ………

….. The research councils are taking UK research down pathways to mediocrity and using peer review as justification. We – the academic community – must stop them, or accept the dire consequences.

Read the whole article


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