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

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More than half of US drug safety studies never see the light of day

 

 

<http://www.guardian.co.uk/science/2008/sep/23/clinical.trialshttp://www.guardia\

n.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.

______________________________\

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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 www.mpwhi.com, www.dorway.com,

www.wnho.net Aspartame Toxicity Center, www.holisticmed.com/aspartame Aspartame

Information List, www.mpwhi.com

 

 

 

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