Adverse drug reactions (ADRs) caused by everyday medicines, or anaesthetics can include depression, anxiety, insomnia, suicidal feelings. Pharmaceutical drugs for pain, infections, acne, anxiety, depression, may cause immediate or withdrawal reactions. Genetic differences may put individuals at risk Refer to our updated web site: www.april.org.uk for extensive information, Please follow us on Twitter @APRIL_charity APRIL (Adverse Psychiatric Reactions Information Link) www.april.org.uk
Showing posts with label Cochrane. Show all posts
Showing posts with label Cochrane. Show all posts
Friday, 10 August 2012
BEWARE OF PHARMACEUTICAL FUNDED STATINS TRIALS PROPAGANDA AND PHARMA MARKETING PRESS RELEASES!
BEWARE OF PHARMACEUTICAL FUNDED STATINS TRIALS PROPAGANDA AND PHARMA MARKETING PRESS RELEASES!
10.08.12, 12:59pm
The Statins promotion article in today's Daily Express entitled ' Statins key to a longer life' is about the Jupiter trial which was funded and sponsored by the manufacturer/marketer to assess the benefits of their drug Crestor (rosuvastatin) The publication of this study in the New England Journal of Medicine in 2008 pushed sales up. Lead/ author of the Jupiter study was the person quoted in the article is Paul Ridker.
One wonders why this article about a trial started in 2003 is appearing now. It may be because of patients’ voices being heard as they share their suffering on Internet forums and can now report adverse drug reactions (ADRs) themselves to the regulator (MHRA) using the Yellow Card system.
A study which examined data from 34,000 patients in 14 clinical trials was published by the Cochrane Library. This respected independent International reviewer of clinical trials pointed out that the majority of trials had been carried out by the manufacturers who may play down possible risks and that some of the patients had suffered memory loss, depression and mood swings. Previous studies linked liver dysfunction, acute kidney failure, cataracts muscle damage to the use of statins. There is also evidence that lowering cholesterol increases cancer risk.
Patients should not be pressured (as I know some are) to say yes to a drug that could reduce their quality of life and should weigh up the benefit- harm ratio. Those taking statins should be aware of early warning signs of the above possible ADRs.
If you are getting muscle problems which may be rhabdomyolysis, a CreatineKinase test will show if the statin is responsible
Millie Kieve founder of www.april.org.uk
this response was • Posted by: MillieAPRIL today on the Daily Express web site at www.express.co.uk/posts/view/338741
Monday, 14 December 2009
Tamiflu BMJ concerns and neuropsychiatric ADRs in trials unreported
British Medical Journal (BMJ)
Editor's Choice
We want raw data, now
Fiona Godlee, editor, BMJ
fgodlee@bmj.com
This week’s BMJ is dominated by a cluster of articles on oseltamivir (Tamiflu) (doi:10.1136/bmj.b5351, doi:10.1136/bmj.b5387, doi:10.1136/bmj.b5106, doi:10.1136/bmj.b5164, doi:10.1136/bmj.b5248, doi:10.1136/bmj.b5364). Between them the articles conclude that the evidence that oseltamivir reduces complications in otherwise healthy people with pandemic influenza is now uncertain and that we need a radical change in the rules on access to trial data.
Briefly, in updating their Cochrane review, published this week (doi:10.1136/bmj.b5106), Tom Jefferson and colleagues failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.
Only after questions were put by the BMJ and Channel 4 News has the manufacturer Roche committed to making "full study reports" available on a password protected site. Some questions remain about who did what in the Roche trials, how patients were recruited, and why some neuropsychiatric adverse events were not reported. A response from Roche is published in our letters pages (doi:10.1136/bmj.b5364) and their full point by point response is published online (doi:10.1136/bmj.b5374).
Should the BMJ be publishing the Cochrane review given that a more complete analysis of the evidence may be possible in the next few months? Yes, because Cochrane reviews are by their nature interim rather than definitive. They exist in the present tense, always to be superseded by the next update. They are based on the best information available to the reviewers at the time they complete their review. The Cochrane reviewers have told the BMJ that they will update their review to incorporate eight unpublished Roche trials when they are provided with individual patient data.
Where does this leave oseltamivir, on which governments around the world have spent billions of pounds? The papers in this week’s journal relate only to its use in healthy adults with influenza. But they say nothing about its use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions; and uncertainty over its role in reducing complications in healthy adults still leaves it as a useful drug for reducing the duration of symptoms. However, as Peter Doshi points out (doi:10.1136/bmj.b5164), on this outcome it has yet to be compared in head to head trials with non-steroidal inflammatory drugs or paracetamol. And given the drug’s known side effects, the risk-benefit profile shifts considerably if we are talking only in terms of symptom relief.
We don’t know yet whether this episode will turn out to be a decisive battle or merely a skirmish in the fight for greater transparency in drug evaluation. But it is a legitimate scientific concern that data used to support important health policy strategies are held only by a commercial organisation and have not been subject to full external scrutiny and review. It can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug. Individual patient data from all trials of drugs should be readily available for scientific scrutiny.
Cite this as: BMJ 2009;339:b5405
Tweet
Editor's Choice
We want raw data, now
Fiona Godlee, editor, BMJ
fgodlee@bmj.com
This week’s BMJ is dominated by a cluster of articles on oseltamivir (Tamiflu) (doi:10.1136/bmj.b5351, doi:10.1136/bmj.b5387, doi:10.1136/bmj.b5106, doi:10.1136/bmj.b5164, doi:10.1136/bmj.b5248, doi:10.1136/bmj.b5364). Between them the articles conclude that the evidence that oseltamivir reduces complications in otherwise healthy people with pandemic influenza is now uncertain and that we need a radical change in the rules on access to trial data.
Briefly, in updating their Cochrane review, published this week (doi:10.1136/bmj.b5106), Tom Jefferson and colleagues failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.
Only after questions were put by the BMJ and Channel 4 News has the manufacturer Roche committed to making "full study reports" available on a password protected site. Some questions remain about who did what in the Roche trials, how patients were recruited, and why some neuropsychiatric adverse events were not reported. A response from Roche is published in our letters pages (doi:10.1136/bmj.b5364) and their full point by point response is published online (doi:10.1136/bmj.b5374).
Should the BMJ be publishing the Cochrane review given that a more complete analysis of the evidence may be possible in the next few months? Yes, because Cochrane reviews are by their nature interim rather than definitive. They exist in the present tense, always to be superseded by the next update. They are based on the best information available to the reviewers at the time they complete their review. The Cochrane reviewers have told the BMJ that they will update their review to incorporate eight unpublished Roche trials when they are provided with individual patient data.
Where does this leave oseltamivir, on which governments around the world have spent billions of pounds? The papers in this week’s journal relate only to its use in healthy adults with influenza. But they say nothing about its use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions; and uncertainty over its role in reducing complications in healthy adults still leaves it as a useful drug for reducing the duration of symptoms. However, as Peter Doshi points out (doi:10.1136/bmj.b5164), on this outcome it has yet to be compared in head to head trials with non-steroidal inflammatory drugs or paracetamol. And given the drug’s known side effects, the risk-benefit profile shifts considerably if we are talking only in terms of symptom relief.
We don’t know yet whether this episode will turn out to be a decisive battle or merely a skirmish in the fight for greater transparency in drug evaluation. But it is a legitimate scientific concern that data used to support important health policy strategies are held only by a commercial organisation and have not been subject to full external scrutiny and review. It can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug. Individual patient data from all trials of drugs should be readily available for scientific scrutiny.
Cite this as: BMJ 2009;339:b5405
Tweet
Subscribe to:
Posts (Atom)