Much attention has been paid to conflicts of interest relating to the pharmaceutical industry, but where do medical journals fit in this equation? A new study notes that journals also have vested interests that warrant disclosure. Specifically, industry-supported clinical trials can boost a journal’s so-called impact factor by generating greater distribution of reprints that increase citation rates and, of course, revenue. The trials are often supported by drugmakers, which purchase reprints.
Read article at pharmalot.com
The following is from http://www4.dr-rath-foundation.org/Newsletter/archive/newsletter_2008_09_sep_23.html
Concern Raised about 'Cancer Publication Bias'
Less than 20 percent of registered clinical trials of cancer treatment are eventually published in medical journals, according to a study published online by the journal "The Oncologist."
Read article at marketwatch.com
Comment: The publication rate was particularly low for "industry-sponsored" studies, such as those funded by pharmaceutical companies -- just 5.9 percent, compared to 59 percent for studies sponsored by collaborative research networks. The researchers suspect that the rate of negative results is much higher in the studies that have gone unpublished.
So you thought all those Vioxx studies in medical journals were independent, hands-off affairs? Not necessarily. An examination of medical journal articles about Vioxx and court documents from Vioxx lawsuits found that Merck employees or ghostwriters were frequently involved in various articles, but the primary authors were often academics who actually had little to do with the studies or didn't always disclose financial ties to Merck.
Read article at pharmalot.com
An examination of medical articles about rofecoxib (a nonsteroidal anti-inflammatory drug) and court documents from litigation related to this product indicates that company employees or other unacknowledged authors were frequently involved in writing clinical trial articles and review articles, but that primary authorship was often attributed to academically affiliated investigators who may have had little to do with the study, or who did not always disclose financial support from the sponsor of the study, according to an article in the April 16 issue of JAMA.
Read article at physorg.com
Law on drugs tests to be tightened
Article in the Telegraph
Extract:
"Drugs companies must reveal the results of clinical trials as soon as they uncover potential problems with their medicines, the Government has announced.
In a statement, Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), has said it will "take immediate steps to ensure the law is strengthened, so that there can be no doubt as to companies' obligations to report safety issues."
The move comes after a four-year investigation into how GlaxoSmithKline (GSK) withheld the full results of their trials into the anti-depressant Seroxat on children.
The Government watchdog criticised the company, which is Europe's biggest drugs manufacturer, for not handing over the trial data earlier.
But it added that criminal charges could not be brought as robust legislation was not in place at the time.
Mr Woods said: "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them.
"This investigation has revealed important weaknesses in the drug safety legislation in force at the time."
The trial data revealed that there was a higher risk of suicidal behaviour among children younger than 18 on Seroxat than those given a placebo.
The results also found that Seroxat was ineffective in dealing with depression in those under 18.
It was handed to the Medicines and Healthcare Regulatory Authority (MHRA) in May 2003, despite GSK having allegedly been aware of the results since 1998.
A month later, in June 2003, the MHRA announced that doctors must stop giving Seroxat to those under 18.
Miss Primarolo will say that GSK should have informed the MHRA earlier than it did, but that the drugs company will not face criminal charges.
The MHRA investigation found that the company could have told them earlier, but did not break the letter of the law by not doing so, as current legislation is not clear as to when a company should reveal the results of its clinical trials."
This is shocking! - I can't say that I've much respect for the MHRA. - It seems to have had mixed loyalties. There's been a lot of GSK (GlaxoSmithKline) cash associated with the bank balances of members of the MHRA.
If anybody is under the misapprehension that the MHRA - Medicines and Healthcare products Regulatory Agency (An executive agency of the Department of Health) is doing a good job and is not overly influenced by or even in the pocket of the drug companies I invite you to read this page, the author of which has a particular interest in the drug, Seroxat - http://fiddaman.blogspot.com/2007_04_05_archive.html - Here is an extract from the page:
"I've looked through the pdf file for THE COMMITTEE ON SAFETY OF MEDICINES ANNUAL REPORT FOR 2004 and will show you all those members who have ties with Glaxosmithkline.
Remember, The Committee on the Safety of Medicines (CSM) was 'apparently' an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines - In other words they offered advice to the MHRA. It was replaced on 30 October 2005 by the Commission on Human Medicines which combines the functions of both the former committee and the Medicines Commission
I've just gone through the declared Personal Interests to highlight the members whom had ties with Glaxosmithkline.
PERSONAL INTERESTS
MEMBER
Professor A Blenkinsopp - GSK Specific – Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research with a Vanillord Receptor antagonist (Consultancy end of 2004)
Professor Albert - GSK Shares
An 'independent' advisory committee huh?"
Drug giants warned: Tell the truth on medicines
Article in the Independent
Experts criticised the stranglehold exerted by multinational companies over clinical trials, which has led to biased results, under-reporting of negative findings and selective publication driven by the market, which was worth £10.1bn in the UK in 2006, amounting to 11 per cent of total NHS costs.
Extract from the article:
"Peter Littlejohns, the clinical and public health director of Nice, said: "The regulatory authorities have access to everything. Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."
Professor Mike Clarke, the director of the UK Cochrane Centre, an international collaboration between researchers in 100 countries which has published more than 3,000 systematic reviews of published trials to establish best medical practice, said lack of co-operation from the drug industry was damaging medical care.
"When we ask for details of a trial the company might tell us nothing. We have even less power than Nice. Researchers trying to make sense of trials for decision-makers need to have access to this data. If we have only got access to half of the data, when we see evidence that a drug works we don't know whether to believe it or not.
"It makes us doubtful – that's the big worry. The companies are in the business of making profits – but they are also in the business of providing safe, effective health care."
Legislation to compel the drug industry to publish its results was included in Labour's manifesto at the 2005 election and last month the Commons Health Select Committee demanded that Nice be given unfettered access to all clinical trial results.
Yesterday, the Government said it had been told that compelling the industry to publish trial data would not be allowed and it was instead pursuing a voluntary approach, developing a "searchable register" of all trials that have taken place in the UK and pressing the EU to make its own confidential register public.
A spokesman for the Department of Health said: "The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law."Lose weight, reduce your risk of most cancers, high blood pressure, type 2 diabetes, stroke, heart disease, vascular dementia, osteopenia, osteoporosis, hypercholesterolaemia, depression, liver and kidney problems, and improve your health in many other ways without drugs or expense by eating less salt! - Try it! - You will feel so much better!
See my website http://www.wildeaboutsteroids.co.uk/.html (The site does not sell anything and has no banners or sponsors or adverts - just helpful information.)
http://www.wildeaboutsteroids.co.uk/steroids.html
http://www.wildeaboutsteroids.co.uk/ami.htmlPharmaceuticals 'need clinical trial regulation'
Never was there a truer statement!
See this report:
Pharmaceuticals 'need clinical trial regulation'
See also Sleaze in the Medical Profession - an earlier entry in this Blog.
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