Fwd: UNCENSORED POST: More than half of US drug safety studies never see the light of day - Scientific Misconduct

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>UNCENSORED POST: More than half of US

>drug safety studies never see the light of day

>editor <editor

>Wed, 24 Sep 2008 06:56:39 +1200

>

>

>UNCENSORED POST

>

>More than half of US drug safety studies

>never see the light of day

>

>

><http://www.guardian.co.uk/science/2008/sep/23/clinical.trials>http://www.guard\

ian.co.uk/science/2008/sep/23/clinical.trials

>

>Only 43% of the evidence of safety and efficacy

>that the US Food and Drug Administration uses to

>approve drugs is published in scientific

>journals. The authors of the survey say this amounts to " scientific misconduct "

>

> * James Randerson

> * guardian.co.uk,

> * Tuesday September 23 2008 10:46 BST

>

>At a pharmacy. Photograph: Alex Wong/Getty Images

>

>Photograph: Alex Wong/Getty Images

>

>The results of more than half of all clinical

>trials that demonstrate the safety and

>effectiveness of new drugs are not published

>within five years of the drug going on the

>market, according to an analysis of 90 drugs

>approved by US regulators between 1998 and 2000.

>

>The researchers, who traced the publication or

>otherwise of 909 separate clinical trials in the

>scientific literature, wrote that the failure of

>drug companies to publish the evidence relating

>to new medicines amounted to " scientific

>misconduct " . They said it " harms the public

>good " by preventing informed decisions by

>doctors and patients about new medicines and by

>hampering future scientific work.

>

>Sir Iain Chalmers, who is director of the James

>Lind Library in Oxford and a founder of the

>Cochrane Collaboration, a respected organisation

>that reviews medical evidence, said that it was

>vital that all data on new medicines be made public.

>

> " Patients may otherwise suffer or die

>unnecessarily, " said Chalmers, who was not

>involved in the work. " The people who

>participate in a trial have a right to expect

>that their participation and their data will be

>made available publicly so that people can take

>whatever decisions seem appropriate in the light of that information. "

>

>The US researchers who carried out the study

>searched the academic literature for publication

>of the trials that drug companies relied on to

>convince the US Food and Drug Administration

>that their new products were safe and effective

>and so worthy of market approval.

>

>Information that is used to convince the

>regulators is not necessarily subsequently

>published for public and scientific scrutiny,

>but the scale of the missing information was found to be vast.

>

>Five years after each of the 90 drugs was first

>available for patients, only 43% of the studies

>supporting the drugs' use had been published,

>with most publication happening in the first one

>or two years. In the case of one product – an

>antibiotic – the researchers could not find a

>single supporting trial in the scientific

>literature, while five trials were published

>twice and one was published three times.

>

>The team also found evidence for a " publication

>bias " . Trials with statistically significant

>results were more likely to be published than

>those with non-significant results, as were those with larger sample sizes.

>

> " In the years immediately following FDA approval

>that are most relevant to public health, there

>exists incomplete and selective publication of

>trials supporting approved new drugs, " Prof Ida

>Sim and her colleagues at the University of

>California, San Francisco, wrote in the journal PLoS Medicine.

>

>One possible explanation for the scientific data

>not being published is that drug companies hold

>back publication of the results that are least

>flattering to their new drugs. Another

>possibility is that academic journal editors are

>less inclined to publish papers on trials that

>have negative or ambiguous results.

>

> " Regardless of the cause, publication bias harms

>the public good by impairing the ability of

>clinicians and patients to make informed

>clinical decisions, and the ability of

>scientists to design safer and more efficient

>trials based on past findings, " the authors

>wrote. " Publication bias can thus be considered

>a form of scientific misconduct. "

>

>The reporting of clinical trial results should

>have improved since the period analysed by the

>researchers, because the 2007 FDA Amendments Act

>mandated basic results reporting for all trials

>supporting FDA-approved drugs and devices.

>However, the researchers said it remained to be

>seen whether clinical reporting would improve.

>

>The new law could even have the opposite effect.

> " Might sponsors feel less compelled to publish

>equivocal trials because the basic results will

>already be in the public domain? " they speculated.

>_____________________________\

___Consider

>aspasrtame: FDA originally asked for indictment

>of manufacturer, revoked the petition for

>approval until Don Rumsfeld called in his

>markers and got it marketed, and admitted to

>Congress it is a carcinogen and violated the

>Delaney Amendment. Yet over a quarter of a

>century later it remains on the market with FDA

>approval as people die from Rumsfeld Plague all over the world.

 

 

Dr. Betty Martini, D.Hum, Founder

Mission Possible International

9270 River Club Parkway

Duluth, Georgia 30097

770 242-2599

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