BMJ editor casts doubt on veracity of statin trials funded by the statin makers - Godlee

Statins for all over 50? No

Fiona Godlee, editor, BMJ

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6412 (Published 23 October 2013)                                         Cite this as: BMJ 2013;347:f6412    

 

Should you prescribe statins to everyone over the age of 50, even those at low cardiovascular risk? A new Cochrane review seems to suggest that you should. An article in this week BMJ cries caution (doi:10.1136/bmj.f6123).

Current guidance from the UK’s National Institute for Health and Care Excellence (NICE) and the American Heart Association recommends statins only when the 10 year risk of cardiovascular disease is 20% or greater. But since these guidelines were written, a large meta-analysis of individual patient data reached a different conclusion. Published in the Lancet in 2012, the Cholesterol Treatment Trialists (CTT) Collaboration meta-analysis found that statins significantly reduced major cardiovascular events and all cause mortality in people at low risk, a benefit which, the paper said, “greatly exceeds any known hazards of statin therapy.”

As John Abramson and colleagues explain, it’s this meta-analysis that led the Cochrane reviewers to embrace the idea that statins should be used far more widely, even perhaps to everyone over 50, as a Lancet editorial suggested at the time.

But Abramson and colleagues’ detailed critique of the CTT meta-analysis should give us pause. Their own analysis of the data finds no evidence of a reduction in all cause mortality or in the total number of serious events. They also highlight the failure of the trials included in the CTT analysis to adequately report important harms of statin treatment, including myopathy and diabetes. They conclude that broadening the use of statins to low risk individuals “will unnecessarily increase the incidence of adverse events without providing overall health benefits.”

There is a concern underlying their critique that will be familiar to BMJ readers. It is that all of the trials included in the CTT meta-analysis were funded by the manufacturer of the statin being studied. They list the various ways in which these trials might have exaggerated the benefits of statins and minimised the harms, and they summarise what low risk patients need to know. Top of the list is the benefit of lifestyle change, something that the dominance of industry sponsored clinical trials too often obscures.

None of this does much to bolster confidence in the published literature. Nor am I reassured by discussions at two recent meetings co-hosted by the European Federation of Pharmaceutical Industry Associations (EFPIA). Drug company AbbVie is suing the European Medicines Agency to stop summary reports of its clinical trials becoming publicly available (doi:10.1136/bmj.f1636). AbbVie’s lawyer made clear that the company considers even the data on adverse events to be commercially confidential. Despite industry’s claims to be in favour of greater transparency, EFPIA and its American counterpart PhRMA are supporting Abbvie. The BMJ and BMA have joined forces to intervene on behalf of the EMA (doi:10.1136/bmj.f4728).

As for a way forward, I can’t improve on the list of solutions proposed by Richard Lehman when emailing out his journal review blog this week (http://bit.ly/HcKvjy): “All phase 3 trials to be designed and conducted independently of manufacturers, using the best available comparator. Research priorities to be determined by patients (James Lind Alliance). Value-based pricing. All data available from all trials, with meta-data: IPD [individual patient data] level for qualified independent centres. Big increase in comparative effectiveness research, much more research into non-pharmacological treatments.”

Notes

Cite this as: BMJ 2013;347:f6412

Footnotes

• Follow BMJ Editor Fiona Godlee on Twitter @fgodlee and the BMJ @bmj_latest

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Emphasis added.

Read the complete article here.

Busted! Scientists leave out data to produce bogus findings

Clinical trials of drugs and other medical therapies are carefully carried out and are the very gold standard of scientific proof, right? According to an in-depth review of this question just published in the British Medical Journal (BMJ,) the answer is no. In fact, the BMJ is sounding the alarm that data reported by scientists is too often not the truth -- because the researchers leave out inconvenient evidence. The result of facts-gone-missing could well be harming patients, spiking up healthcare costs by the selling of medical treatments based on bogus findings, and threatening the very integrity of medicine.

These warnings come from multiple papers released by the BMJ. The whistle-blowing authors of these articles examined the extent, causes, consequences of hidden facts, figures, and other data scientists discover as they do human trials. It turns out this is no "once in a while" kind of problem, either. The BMJ claims a "large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately."

In an editorial, Dr. Richard Lehman from the University of Oxford and BMJ Clinical Epidemiology Editor, Dr. Elizabeth Loder, nail the current state of medical research as a "culture of haphazard publication and incomplete data disclosure." They call for full access to raw trial data to allow better understanding of the benefits and harms of many treatments.

Bottom line: when data is left out, the missing facts distort the scientific record and published results of a study. This then leads doctors to make potentially dangerous clinical decisions about what drugs or procedures patients need because the docs are relying on skewed and even bogus "evidence."

Conveniently missing facts left out of drug trials and more

Papers in the current issue of BMJ include a study by Dr. Beth Hart and colleagues, which document how unpublished data is "conveniently missing" from many published meta-analyses of drug trials. That's right. Big Pharma's pills and potions are often pushed based on studies that simply ignore and leave out major data about what was really discovered about a medication lacking of benefits, potential dangers, side effects and more. Dr. Hart's team argues that access to full trial data is necessary to allow drugs to be independently assessed.

Two additional studies show the requirements for mandatory trial registration and timely sharing of results are poorly followed, if at all. For example, it turns out that less than half of US National Institutes of Health funded trials are published in a peer reviewed journal within 30 months of completion and only 22 percent of trials that are supposed to be subject to mandatory reporting had results available within one year of completion.

"When the word mandatory turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear," the researchers report.

And what happens when ethical, dedicated scientists try to assess true harms vs benefits of Big Pharma drugs and other interventions? It's not a pretty picture for their careers, apparently. Additional studies published in the special BMJ issue highlight the many difficulties these researchers face when they try to buck the system.

Dr. Lehman and Dr. Loder, however, are bravely speaking out and directly saying that a concealment of data in clinical trials is anything but unusual. They label this "a serious ethical breach" and demand that clinical researchers who fail to disclose data "should be subject to disciplinary action by professional organizations. These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine."

For more information:

http://www.bmj.com/

http://www.naturalnews.com/medical_errors.html

Learn more: http://www.naturalnews.com/034577_quack_science_clinical_trials_BMJ.html#ixzz1iaunAKmd