Posted on February 24, 2015 by lucas2012infos | Leave a comment
(NaturalNews) When there are problems in medical research, the U.S. Food and Drug Administration, deferring to its partners in Big Pharma, won’t always tell you about it.
As reported recently by Reuters, the agency has found major discrepancies in dozens of final reports issued by medical researchers regarding the manner in which they collected their data. But the FDA regularly failed to publicize its findings.
Reuters further reported:
Out of 78 published papers reporting on clinical trials in which the U.S. Food and Drug Administration found very serious issues, only three mentioned any violations, the new report says.
“These are major things,” Charles Seife, a journalism professor and the study’s author, commented.
Examining documents and data from 1998 to 2013, Seife and some of his students at New York University in New York City found 57 clinical trials that came with an “official action indicated” violation, which is the most serious of all trials violations, for reasons such as poor record keeping, the falsification of information and poor patient safety.
In one study, a patient died – but it wasn’t reported
As further reported by The Verge, Seife blamed “regulatory capture” for the lapses in ethics, which the website described as “a type of corruption where a public agency protects the interests of the groups it’s meant to regulate rather than the interests of the public at large.”
Of the three that noted violations, they included researchers falsifying data and some patients being included in trials despite not being eligible to take part in them, Reuters reported.
Reports noted that some of the problems with research that were not reported were quite serious. One of the papers, for instance, claimed that all patients reported an improvement, but in reality, the FDA found that one of the patients in that body of research had to have a foot amputated two weeks after receiving treatment.
In yet another case, the entire body of research — the whole clinical trial — was deemed unreliable by the FDA’s scientists, though the published paper failed to note that.
In yet another paper, researchers falsified data, and that led to one patient dying.
Reuters further noted that data on the violations was not made readily available. As such, Seife said that it is impossible to determine how often bad data is published and how often violations are actually made public by the FDA.
“No one really knows unless you go through these documents that anyone is questioning the integrity of the trials,” he said.
Seife further noted that physicians would certainly want to know if the FDA had discovered major problems with data collection in research studies, since they would no doubt be utilizing such data to decide what medicines are the best choices for their patients.
In addition, medical journal editorial boards ought to be concerned, because they are essentially enabling the phony data by publishing the tainted research, which undermines the credibility of their journals.
This is a big concern
“This study highlights some disturbing examples where articles were published and information was lacking and this would be a concern to readers,” Dr. Robert Steinbrook, an editor at large at the publication JAMA Internal Medicine. He co-authored an editorial that was published along with Seife’s report .
“What this does is call attention to a communication issue,” Steinbrook, who is also affiliated with the Yale School of Medicine, said.
Though correspondence with the FDA has somewhat improved on such issues, the researchers’ “suggestion is to go further.”
His editorial, along with the study, recommend that clinical trial inspection reports be included in the U.S. government’s database with research located at ClinicalTrials.gov.
In a statement to Reuters, the FDA said the agency “is committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decisions, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products.”
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